freefdawatchlist's Instablog I am author of http://www.freefdawatchlist.com freefdawatchlist http://seekingalpha.com/user/1087975/instablog Earning Play For April 1st - 5th: CALM, BBBY, PBY, OXM, GIII, CAG, WDFC, MON, RPM, GPN, MKC http://seekingalpha.com/instablog/1087975-freefdawatchlist/1703961-earning-play-for-april-1st-5th-calm-bbby-pby-oxm-giii-cag-wdfc-mon-rpm-gpn-mkc?source=feed 1703961 www.freefdawatchlist.com/2013/03/earning....html

Earning play is very risky as this market is not normal anymore. Stock on good earning report can be down and some that misses earning can rally. The best way to play this stock is before, and after the earning is reported. I'll be following BBBY, GIII, GPN, MKC for this week.

 

 

No.TickerMarket CapPerf HalfPerf YearPerf YTDPriceVolumeEarnings
1CALM1.02B-1.64%11.47%6.32%42.5671,337Apr 01/b
2RPM4.18B10.57%27.29%7.56%31.58569,241Apr 01
3SCVL417.59M-8.79%-4.08%-0.24%20.44131,893Apr 01/a
4BONA559.41M-15.90%-12.55%-6.50%4.6024,978Apr 01/a
5MKC8.84B16.99%41.66%15.77%73.55753,312Apr 02/b
6BBBY14.57B4.00%-4.18%15.22%64.422,613,743Apr 02
7ISCA1.52B13.87%24.83%18.19%32.6894,580Apr 02
8PBY626.05M13.80%-20.93%19.94%11.79293,043Apr 02
9RECN520.70M-4.65%-3.71%6.99%12.70226,392Apr 02/a
10OXM879.87M-9.22%6.71%14.89%53.10291,708Apr 02/a
11GIII806.21M10.95%39.46%17.18%40.11459,535Apr 02/a
12GPN3.91B13.64%-6.97%9.67%49.66696,746Apr 02/a
13CONN1.23B57.08%120.49%17.22%35.94425,719Apr 03/b
14CAG14.86B32.24%42.33%22.34%35.812,992,430Apr 03/b
15AYI2.97B6.51%9.87%2.59%69.35486,751Apr 03/b
16OMN359.42M-12.54%11.64%9.42%7.67246,794Apr 03/b
17MON56.60B16.96%34.00%12.04%105.632,772,955Apr 03/b
18ELRC444.96M13.46%8.93%21.89%18.5467,193Apr 03
19WDFC854.41M3.79%23.05%17.00%54.7729,711Apr 04
20AZZ1.22B37.60%84.11%25.85%48.2091,327Apr 05

]]> Mon, 01 Apr 2013 08:23:04 -0400 www.freefdawatchlist.com/2013/03/earning....html

Earning play is very risky as this market is not normal anymore. Stock on good earning report can be down and some that misses earning can rally. The best way to play this stock is before, and after the earning is reported. I'll be following BBBY, GIII, GPN, MKC for this week.

 

 

No.TickerMarket CapPerf HalfPerf YearPerf YTDPriceVolumeEarnings
1CALM1.02B-1.64%11.47%6.32%42.5671,337Apr 01/b
2RPM4.18B10.57%27.29%7.56%31.58569,241Apr 01
3SCVL417.59M-8.79%-4.08%-0.24%20.44131,893Apr 01/a
4BONA559.41M-15.90%-12.55%-6.50%4.6024,978Apr 01/a
5MKC8.84B16.99%41.66%15.77%73.55753,312Apr 02/b
6BBBY14.57B4.00%-4.18%15.22%64.422,613,743Apr 02
7ISCA1.52B13.87%24.83%18.19%32.6894,580Apr 02
8PBY626.05M13.80%-20.93%19.94%11.79293,043Apr 02
9RECN520.70M-4.65%-3.71%6.99%12.70226,392Apr 02/a
10OXM879.87M-9.22%6.71%14.89%53.10291,708Apr 02/a
11GIII806.21M10.95%39.46%17.18%40.11459,535Apr 02/a
12GPN3.91B13.64%-6.97%9.67%49.66696,746Apr 02/a
13CONN1.23B57.08%120.49%17.22%35.94425,719Apr 03/b
14CAG14.86B32.24%42.33%22.34%35.812,992,430Apr 03/b
15AYI2.97B6.51%9.87%2.59%69.35486,751Apr 03/b
16OMN359.42M-12.54%11.64%9.42%7.67246,794Apr 03/b
17MON56.60B16.96%34.00%12.04%105.632,772,955Apr 03/b
18ELRC444.96M13.46%8.93%21.89%18.5467,193Apr 03
19WDFC854.41M3.79%23.05%17.00%54.7729,711Apr 04
20AZZ1.22B37.60%84.11%25.85%48.2091,327Apr 05

]]> calm bbby pby oxm giii cag wdfc mon rpm gpn mkc Comparison Of Federal Reserve Total Assets Vs S&P500 For March 28th http://seekingalpha.com/instablog/1087975-freefdawatchlist/1702231-comparison-of-federal-reserve-total-assets-vs-s-p500-for-march-28th?source=feed 1702231 http://www.freefdawatchlist.com/2013/03/comparison-of-federal-reserve-total.html

As of March 28th, Federal Reserve Total Assets is at a current level of 3.204T, down from 3.209T last week and up from 2.895T one year ago. This is a change of -0.14% from last week and 10.67% from one year ago. This data is released every Thursday at 4.30 pm. I'll be updating this chart every week.
(click to enlarge)
Comparison of S&P500 vs Federal Reserve Total Assets for year to date.

Finally Fed paused their machine for small break, so expect pull back next week to 1540 level.

Printing Press machine is ON as if world will end. Below is the list how Federal Reserve total assets increased their asset in last 6 month. This is one of the main reason why VIX is so depressed and stock like UVXY, VXX, TVIX is under performing as they are still in contango.

March 27, 20133.204T
March 20, 20133.209T
March 13, 20133.167T
March 6, 20133.110T
Feb. 27, 20133.092T
Feb. 20, 20133.097T
Feb. 13, 20133.076T
Feb. 6, 20133.017T
Jan. 30, 20133.010T
Jan. 23, 20133.013T
Jan. 16, 20132.965T
Jan. 9, 20132.930T
Jan. 2, 20132.919T
Dec. 26, 20122.909T
Dec. 19, 20122.922T
Dec. 12, 20122.919T
Dec. 5, 20122.861T
Nov. 28, 20122.853T
Nov. 21, 20122.873T
Nov. 14, 20122.879T
Nov. 7, 20122.832T
Oct. 31, 20122.825T

Below is the list of Fed POMO schedule for April which begins at 10.15 am EST and the result is out at 2pm EST


PURCHASE OPERATIONS
OPERATION DATE1SETTLEMENT DATEOPERATION TYPEMATURITY RANGEEXPECTED PURCHASE SIZE
Mon, Apr 01, 2013Tue, Apr 02, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Tue, Apr 02, 2013Wed, Apr 03, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Wed, Apr 03, 2013Thu, Apr 04, 2013Outright Treasury Coupon Purchases01/31/2019 - 03/31/2020$3.00 - $3.75 billion
Thu, Apr 04, 2013Fri, Apr 05, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Mon, Apr 08, 2013Tue, Apr 09, 2013Outright TIPS Purchases04/15/2017 - 02/15/2043$1.00 - $1.50 billion
Tue, Apr 09, 2013Wed, Apr 10, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Thu, Apr, 11, 2013Fri, Apr 12, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Fri, Apr 12, 2013Mon, Apr 15, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Mon, Apr 15, 2013Tue, Apr 16, 2013Outright Treasury Coupon Purchases01/31/2018 - 12/31/2018$4.75 - $5.75 billion
Wed, Apr 17, 2013Thu, Apr 18, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Thu, Apr 18, 2013Fri, Apr 19, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Fri, Apr 19, 2013Mon, Apr 22, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Mon, Apr 22, 2013Tue, Apr 23, 2013Outright Treasury Coupon Purchases01/31/2019 - 03/31/2020$3.00 - $3.75 billion
Tue, Apr 23, 2013Wed, Apr 24, 2013Outright Treasury Coupon Purchases08/15/2023 - 02/15/2031$0.75 - $1.00 billion
Wed, Apr 24, 2013Thu, Apr 25, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Fri, Apr 26, 2013Mon, Apr 29, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Mon, Apr 29, 2013Tue, Apr 30, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Tue, Apr 30, 2013Wed, May 01, 2013Outright Treasury Coupon Purchases04/30/2017 - 12/31/2017$4.25 - $5.25 billion

]]> Fri, 29 Mar 2013 10:41:24 -0400 http://www.freefdawatchlist.com/2013/03/comparison-of-federal-reserve-total.html

As of March 28th, Federal Reserve Total Assets is at a current level of 3.204T, down from 3.209T last week and up from 2.895T one year ago. This is a change of -0.14% from last week and 10.67% from one year ago. This data is released every Thursday at 4.30 pm. I'll be updating this chart every week.
(click to enlarge)
Comparison of S&P500 vs Federal Reserve Total Assets for year to date.

Finally Fed paused their machine for small break, so expect pull back next week to 1540 level.

Printing Press machine is ON as if world will end. Below is the list how Federal Reserve total assets increased their asset in last 6 month. This is one of the main reason why VIX is so depressed and stock like UVXY, VXX, TVIX is under performing as they are still in contango.

March 27, 20133.204T
March 20, 20133.209T
March 13, 20133.167T
March 6, 20133.110T
Feb. 27, 20133.092T
Feb. 20, 20133.097T
Feb. 13, 20133.076T
Feb. 6, 20133.017T
Jan. 30, 20133.010T
Jan. 23, 20133.013T
Jan. 16, 20132.965T
Jan. 9, 20132.930T
Jan. 2, 20132.919T
Dec. 26, 20122.909T
Dec. 19, 20122.922T
Dec. 12, 20122.919T
Dec. 5, 20122.861T
Nov. 28, 20122.853T
Nov. 21, 20122.873T
Nov. 14, 20122.879T
Nov. 7, 20122.832T
Oct. 31, 20122.825T

Below is the list of Fed POMO schedule for April which begins at 10.15 am EST and the result is out at 2pm EST


PURCHASE OPERATIONS
OPERATION DATE1SETTLEMENT DATEOPERATION TYPEMATURITY RANGEEXPECTED PURCHASE SIZE
Mon, Apr 01, 2013Tue, Apr 02, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Tue, Apr 02, 2013Wed, Apr 03, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Wed, Apr 03, 2013Thu, Apr 04, 2013Outright Treasury Coupon Purchases01/31/2019 - 03/31/2020$3.00 - $3.75 billion
Thu, Apr 04, 2013Fri, Apr 05, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Mon, Apr 08, 2013Tue, Apr 09, 2013Outright TIPS Purchases04/15/2017 - 02/15/2043$1.00 - $1.50 billion
Tue, Apr 09, 2013Wed, Apr 10, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Thu, Apr, 11, 2013Fri, Apr 12, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Fri, Apr 12, 2013Mon, Apr 15, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Mon, Apr 15, 2013Tue, Apr 16, 2013Outright Treasury Coupon Purchases01/31/2018 - 12/31/2018$4.75 - $5.75 billion
Wed, Apr 17, 2013Thu, Apr 18, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Thu, Apr 18, 2013Fri, Apr 19, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Fri, Apr 19, 2013Mon, Apr 22, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Mon, Apr 22, 2013Tue, Apr 23, 2013Outright Treasury Coupon Purchases01/31/2019 - 03/31/2020$3.00 - $3.75 billion
Tue, Apr 23, 2013Wed, Apr 24, 2013Outright Treasury Coupon Purchases08/15/2023 - 02/15/2031$0.75 - $1.00 billion
Wed, Apr 24, 2013Thu, Apr 25, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Fri, Apr 26, 2013Mon, Apr 29, 2013Outright Treasury Coupon Purchases05/15/2020 - 02/15/2023$2.75 - $3.50 billion
Mon, Apr 29, 2013Tue, Apr 30, 2013Outright Treasury Coupon Purchases02/15/2036 - 02/15/2043$1.25 - $1.75 billion
Tue, Apr 30, 2013Wed, May 01, 2013Outright Treasury Coupon Purchases04/30/2017 - 12/31/2017$4.25 - $5.25 billion

]]> spxu spy vxx uvxy tvix xiv tza tna fas faz dia long term Earning Play For March 11th - 15th: RUE, STEI, HEK, DMND, AMED,FDS, EGL, PHMD, GES, HOTT, SNTA, EBIX, PRKR, DOLE, VRA, HIBB, SNSS http://seekingalpha.com/instablog/1087975-freefdawatchlist/1633211-earning-play-for-march-11th-15th-rue-stei-hek-dmnd-amed-fds-egl-phmd-ges-hott-snta-ebix-prkr-dole-vra-hibb-snss?source=feed 1633211
 

 

No.TickerCompanyPerf HalfPerf YTD50D HighPriceChangeEarnings
1RUErue21, Inc.-2.21%-1.62%-10.51%27.93-0.29%Mar 11
2STEIStewart Enterprises Inc.18.24%17.93%-0.88%9.011.01%Mar 11/a
3HEKHeckmann Corporation-3.50%-11.17%-17.70%3.580.85%Mar 11/a
4DMNDDiamond Foods, Inc.-8.40%28.46%-1.07%17.561.50%Mar 11/a
5AMEDAmedisys Inc.-20.20%4.07%-11.90%11.770.43%Mar 12/b
6FDSFactSet Research Systems Inc.6.46%13.20%-0.41%99.37-0.38%Mar 12
7EGLEngility Holdings, Inc.6.03%-0.42%-4.96%19.180.79%Mar 12/a
8PHMDPhotoMedex, Inc11.33%1.45%-5.27%14.740.27%Mar 13/b
9GESGuess' Inc.14.57%15.97%-2.80%28.462.04%Mar 13
10HOTTHot Topic Inc.48.39%43.61%-0.86%13.83-0.29%Mar 13/a
11SNTASynta Pharmaceuticals Corp.29.63%8.65%-17.51%9.801.77%Mar 14/b
12EBIXEbix Inc.-35.94%-4.03%-22.03%15.47-0.90%Mar 14/b
13PRKRParkervision Inc.75.21%101.97%-6.61%4.104.06%Mar 14
14DOLEDole Food Company Inc.-9.38%1.92%-3.31%11.690.60%Mar 14
15VRAVera Bradley, Inc.15.82%-3.19%-10.50%24.301.76%Mar 14/a
16HIBBHibbett Sports, Inc.-9.87%0.47%-4.41%52.95-2.27%Mar 15/b
17SNSSSunesis Pharmaceuticals Inc.87.11%41.67%-9.02%5.951.88%Mar 15
]]> Sun, 10 Mar 2013 08:10:59 -0400
 

 

No.TickerCompanyPerf HalfPerf YTD50D HighPriceChangeEarnings
1RUErue21, Inc.-2.21%-1.62%-10.51%27.93-0.29%Mar 11
2STEIStewart Enterprises Inc.18.24%17.93%-0.88%9.011.01%Mar 11/a
3HEKHeckmann Corporation-3.50%-11.17%-17.70%3.580.85%Mar 11/a
4DMNDDiamond Foods, Inc.-8.40%28.46%-1.07%17.561.50%Mar 11/a
5AMEDAmedisys Inc.-20.20%4.07%-11.90%11.770.43%Mar 12/b
6FDSFactSet Research Systems Inc.6.46%13.20%-0.41%99.37-0.38%Mar 12
7EGLEngility Holdings, Inc.6.03%-0.42%-4.96%19.180.79%Mar 12/a
8PHMDPhotoMedex, Inc11.33%1.45%-5.27%14.740.27%Mar 13/b
9GESGuess' Inc.14.57%15.97%-2.80%28.462.04%Mar 13
10HOTTHot Topic Inc.48.39%43.61%-0.86%13.83-0.29%Mar 13/a
11SNTASynta Pharmaceuticals Corp.29.63%8.65%-17.51%9.801.77%Mar 14/b
12EBIXEbix Inc.-35.94%-4.03%-22.03%15.47-0.90%Mar 14/b
13PRKRParkervision Inc.75.21%101.97%-6.61%4.104.06%Mar 14
14DOLEDole Food Company Inc.-9.38%1.92%-3.31%11.690.60%Mar 14
15VRAVera Bradley, Inc.15.82%-3.19%-10.50%24.301.76%Mar 14/a
16HIBBHibbett Sports, Inc.-9.87%0.47%-4.41%52.95-2.27%Mar 15/b
17SNSSSunesis Pharmaceuticals Inc.87.11%41.67%-9.02%5.951.88%Mar 15
]]> call rue stei hek dmnd amed fds egl phmd ges hott snta ebix prkr dole vra hibb snss Earning Play UPCOMING FDA APPROVAL IN DECEMBER - JANUARY: EXEL, THRX, ONXX, ZGNX, PATH, HEB http://seekingalpha.com/instablog/1087975-freefdawatchlist/1306401-upcoming-fda-approval-in-december-january-exel-thrx-onxx-zgnx-path-heb?source=feed 1306401 www.freefdawatchlist.com/2012/11/upcomin....

Below are the list of companies waiting for FDA approval. Here is a guideline you should keep in mind while buying /shorting this stocks.

  • If a stocks get FDA approval, it jumps 30-40% easily but it depends on market cap.
  • If the market cap is below 1B and FDA denies or give complete response letter then the stocks falls down by 30-40%. For market cap above 5 -10B, there is movement of up or down by 2%.
  • Buying activity in stock starts 3-4 month ahead of FDA decision. Selling activity starts after 3 days of approval.
  • If FDA panel decision doesn't back up drug, it will fall. After FDA panel decision, official approval from FDA comes within 1 month.
  • If FDA panel back any stock, it will keep rising till it gets final decision. On final decision date, if stock get approval, stock rises in the morning and then it falls.
  • On receiving complete response, stocks falls and keep falling for atleast 15 -20 days. Buying activity starts after 15 days on anticipation that company will resubmit for FDA approval.
  • Delay of 3 month from Fda can lead to 10% drop.

November 29th EXELIXIS INC (EXEL) FDA decision on Cabozantinib for metastatic medullary thyroid cancer

November 29th THERAVANCE, INC.(THRX) FDA panel to review VIBATIV for treatment of nosocomial pneumonia.

November 28th, 2012: Bayer HealthCare and Onyx Pharmaceuticals (Nasdaq: ONXX) FDA Approval for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

December 7th, Zogenix, Inc. (ZGNX) FDA panel to review Zohydro ER for management of chronic pain

December 8th, 2012: BioMimetic Therapeutics, Inc. (Nasdaq: BMTI), Fda approval for Augment(R) Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures.

December 15th: GlaxoSmithKline (GSK) Fda approval for the anthrax treatment raxibacumab.

December 16th, 2012: NuPathe Inc. (Nasdaq: PATH), New Drug Application (NDA), FDA approval for its migraine patch (NP101)

December 20th Hemispherx Biopharma, Inc.(HEB) FDA panel to review Ampligen for Chronic Fatigue Syndrome.

December 21st. Alexza (Nasdaq: ALXA) seeking approval for ADASUVE for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

December 28th Biogen Idec (BIIB) FDA decision on BG-12 for treatment of multiple sclerosis

December 30th NPS Pharmaceuticals Inc (NPSP) FDA decision on Gattex for treatment of short bowel syndrome in adults.

January 16th: Santarus Inc. (SNTS) FDA decision on UCERIS for induction of remission of mild to moderate active ulcerative colitis.

January 17th: NuPathe Inc.(PATH) FDA decision on Zecuity for treatment of migraine.

January 20th: Raptor Pharmaceuticals Corp. (RPTP) FDA decision on RP103 for potential treatment of nephropathic cystinosis

January 21st: Impax Laboratories Inc (IPXL) FDA decision on Rytary for treatment of idiopathic Parkinson's disease

January 23rd: Hyperion Therapeutics, Inc. (HPTX) FDA decision on Ravicti for treatment of urea cycle disorder.

January 29th: ISIS Pharmaceuticals Inc (ISIS) FDA decision on KYNAMRO for treatment of patients with homozygous familial hypercholesterolemia.

January 30th, 2013: Raptor Pharmaceutical Corp. (Nasdaq:RPTP), Cysteamine Bitartrate Delayed-Release Capsules ("RP103"), for the potential treatment of nephropathic cystinosis.

February 10th: Celgene Corporation (CELG) FDA decision on Pomalidomide for treatment of relapsed and refractory multiple myeloma.

Complete Response Letter:

10/29/2012 Cornerstone Therapeutics Inc.(CRTX) FDA decision on Lixivaptan, formerly CRTX 080, for treatment of hyponatremia

10/27/2012 United Therapeutics Corp(UTHR) FDA decision on oral Treprostinil for pulmonary arterial hypertension

09/10/2012 Navidea Biopharmaceuticals, Inc.(NEOP, NAVB) FDA rejects Lymphoseek, citing manufacturing deficiencies.

The U.S. Food & Drug Administration has sent Salix Pharmaceuticals Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) a Complete Response Letter (CRL) regarding the drug Relistor's supplemental new drug application. Relistor is an injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients who suffer from chronic, noncancer pain.

06/21/2012 RGEN SecreFlo (NDA) FDA issues complete response letter for SecreFlo (RG1068)
06/05/2012 ARIA FDA issues complete response letter for Ridaforolimus. Says additional trial(s) would need to be conducted to further assess safety and efficacy.
05/04/2012 ALXA FDA issues complete response letter for Adasuve
04/26/2012 AMGN FDA issues Complete Response Letter for addnl. indication of XGEVA
04/25/2012 FURX FDA issues complete response letter for Alogliptin, and fixed-dose combination therapy Alogliptin and Pioglitazone.
04/16/2012 NRI.TO Pliaglis (sNDA) FDA issued complete response letter for Pliaglis
03/28/2012 CHTP FDA issues complete response letter for Northera
03/26/2012 MAPP FDA issued complete response letter for Levadex

]]> Sat, 24 Nov 2012 14:40:05 -0500 www.freefdawatchlist.com/2012/11/upcomin....

Below are the list of companies waiting for FDA approval. Here is a guideline you should keep in mind while buying /shorting this stocks.

  • If a stocks get FDA approval, it jumps 30-40% easily but it depends on market cap.
  • If the market cap is below 1B and FDA denies or give complete response letter then the stocks falls down by 30-40%. For market cap above 5 -10B, there is movement of up or down by 2%.
  • Buying activity in stock starts 3-4 month ahead of FDA decision. Selling activity starts after 3 days of approval.
  • If FDA panel decision doesn't back up drug, it will fall. After FDA panel decision, official approval from FDA comes within 1 month.
  • If FDA panel back any stock, it will keep rising till it gets final decision. On final decision date, if stock get approval, stock rises in the morning and then it falls.
  • On receiving complete response, stocks falls and keep falling for atleast 15 -20 days. Buying activity starts after 15 days on anticipation that company will resubmit for FDA approval.
  • Delay of 3 month from Fda can lead to 10% drop.

November 29th EXELIXIS INC (EXEL) FDA decision on Cabozantinib for metastatic medullary thyroid cancer

November 29th THERAVANCE, INC.(THRX) FDA panel to review VIBATIV for treatment of nosocomial pneumonia.

November 28th, 2012: Bayer HealthCare and Onyx Pharmaceuticals (Nasdaq: ONXX) FDA Approval for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

December 7th, Zogenix, Inc. (ZGNX) FDA panel to review Zohydro ER for management of chronic pain

December 8th, 2012: BioMimetic Therapeutics, Inc. (Nasdaq: BMTI), Fda approval for Augment(R) Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures.

December 15th: GlaxoSmithKline (GSK) Fda approval for the anthrax treatment raxibacumab.

December 16th, 2012: NuPathe Inc. (Nasdaq: PATH), New Drug Application (NDA), FDA approval for its migraine patch (NP101)

December 20th Hemispherx Biopharma, Inc.(HEB) FDA panel to review Ampligen for Chronic Fatigue Syndrome.

December 21st. Alexza (Nasdaq: ALXA) seeking approval for ADASUVE for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

December 28th Biogen Idec (BIIB) FDA decision on BG-12 for treatment of multiple sclerosis

December 30th NPS Pharmaceuticals Inc (NPSP) FDA decision on Gattex for treatment of short bowel syndrome in adults.

January 16th: Santarus Inc. (SNTS) FDA decision on UCERIS for induction of remission of mild to moderate active ulcerative colitis.

January 17th: NuPathe Inc.(PATH) FDA decision on Zecuity for treatment of migraine.

January 20th: Raptor Pharmaceuticals Corp. (RPTP) FDA decision on RP103 for potential treatment of nephropathic cystinosis

January 21st: Impax Laboratories Inc (IPXL) FDA decision on Rytary for treatment of idiopathic Parkinson's disease

January 23rd: Hyperion Therapeutics, Inc. (HPTX) FDA decision on Ravicti for treatment of urea cycle disorder.

January 29th: ISIS Pharmaceuticals Inc (ISIS) FDA decision on KYNAMRO for treatment of patients with homozygous familial hypercholesterolemia.

January 30th, 2013: Raptor Pharmaceutical Corp. (Nasdaq:RPTP), Cysteamine Bitartrate Delayed-Release Capsules ("RP103"), for the potential treatment of nephropathic cystinosis.

February 10th: Celgene Corporation (CELG) FDA decision on Pomalidomide for treatment of relapsed and refractory multiple myeloma.

Complete Response Letter:

10/29/2012 Cornerstone Therapeutics Inc.(CRTX) FDA decision on Lixivaptan, formerly CRTX 080, for treatment of hyponatremia

10/27/2012 United Therapeutics Corp(UTHR) FDA decision on oral Treprostinil for pulmonary arterial hypertension

09/10/2012 Navidea Biopharmaceuticals, Inc.(NEOP, NAVB) FDA rejects Lymphoseek, citing manufacturing deficiencies.

The U.S. Food & Drug Administration has sent Salix Pharmaceuticals Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) a Complete Response Letter (CRL) regarding the drug Relistor's supplemental new drug application. Relistor is an injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients who suffer from chronic, noncancer pain.

06/21/2012 RGEN SecreFlo (NDA) FDA issues complete response letter for SecreFlo (RG1068)
06/05/2012 ARIA FDA issues complete response letter for Ridaforolimus. Says additional trial(s) would need to be conducted to further assess safety and efficacy.
05/04/2012 ALXA FDA issues complete response letter for Adasuve
04/26/2012 AMGN FDA issues Complete Response Letter for addnl. indication of XGEVA
04/25/2012 FURX FDA issues complete response letter for Alogliptin, and fixed-dose combination therapy Alogliptin and Pioglitazone.
04/16/2012 NRI.TO Pliaglis (sNDA) FDA issued complete response letter for Pliaglis
03/28/2012 CHTP FDA issues complete response letter for Northera
03/26/2012 MAPP FDA issued complete response letter for Levadex

]]> exel thrx onxx zgnx path heb MY BEST PREDICTION: DOWNFALL OF APPLE INC.(NASDAQ:AAPL) http://seekingalpha.com/instablog/1087975-freefdawatchlist/1283731-my-best-prediction-downfall-of-apple-inc-nasdaq-aapl?source=feed 1283731 So far my accuracy for predicting stock direction has been accurate based on chart. Here is how Apple Inc fell from 702 to 529 level. The rule is very simple just follow the trend. Here is an example of the actual AAPL chart frise and fall.

http://www.freefdawatchlist.com/2012/11/my-best-prediction-downfall-of-apple.html

(click to enlarge)
September 10th AAPL chart
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September 14th AAPL chart

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September 19th: AAPL chart

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Sept 24th Chart:
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Sept 25th Chart
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Sept 25th chart
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Sept 28th
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Oct 1st Chart
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Oct 5th
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Oct 12th chart
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Oct 15th
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Oct 25th chart
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Oct 26th
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Nov 2nd chart
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Nov 13th chart

]]> Fri, 16 Nov 2012 02:07:17 -0500 So far my accuracy for predicting stock direction has been accurate based on chart. Here is how Apple Inc fell from 702 to 529 level. The rule is very simple just follow the trend. Here is an example of the actual AAPL chart frise and fall.

http://www.freefdawatchlist.com/2012/11/my-best-prediction-downfall-of-apple.html

(click to enlarge)
September 10th AAPL chart
(click to enlarge)
September 14th AAPL chart

(click to enlarge)
September 19th: AAPL chart

(click to enlarge)
Sept 24th Chart:
(click to enlarge)
Sept 25th Chart
(click to enlarge)
Sept 25th chart
(click to enlarge)
Sept 28th
(click to enlarge)
Oct 1st Chart
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Oct 5th
(click to enlarge)
Oct 12th chart
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Oct 15th
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Oct 25th chart
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Oct 26th
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Nov 2nd chart
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Nov 13th chart

]]> aapl spy qqq xlk goog BEARISH CALL ON BMRN: 3K PATIENT WORLDWIDE CANNOT GENERATE 775 MILLION. PT $40 http://seekingalpha.com/instablog/1087975-freefdawatchlist/1247401-bearish-call-on-bmrn-3k-patient-worldwide-cannot-generate-775-million-pt-40?source=feed 1247401 http://www.freefdawatchlist.com/2012/11/bearish-call-on-bmrn-3k-patient.html

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the pivotal Phase 3 study of GALNS met the primary endpoint of change in six-minute walk distance compared with placebo at 24 weeks in subjects receiving weekly infusions of GALNS at the dose of 2 mg/kg (p=0.0174). MOR-004 was a randomized, double-blind, placebo-controlled study evaluating two doses of GALNS (BMN-110, N- acetylgalactosamine-6-sulfatase) for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. Morquio A syndrome is estimated to occur in 1 in 200,000 to 300,000 live births.

(click to enlarge)

The rate of incidence of MPS IVA is as yet unconfirmed and varies among different populations but estimates vary between 1 in 200,000 live births and 1 in 250,000 live births. The estimated prevalence is between 1,000 and 1,500 patients in the U.S., EU and Japan and between 1,500 to 2,000 patients in the rest of the world for a total of 2,500 to 3,000 patients.

http://investors.bmrn.com/releasedetail.cfm?ReleaseID=718462
Anticipated Upcoming Milestones for Biomarin

4Q 2012: Results for Phase 3 trial for GALNS for MPS IVA
4Q 2012: Update on Phase 1/2 trial for BMN-673 for solid tumors
1Q 2013: Market authorization application filing for GALNS for MPS IVA
1Q 2013: Results for Phase 1/2 trial for BMN-701 for Pompe disease
1H 2013: IND filing for BMN-190 for LINCL (Batten disease)
2Q 2013: Initiation of Phase 3 trial for PEG-PAL for PKU
2Q 2013: Results for PKU-016 Kuvan neurocognitive study
Mid 2013: Initiation of Phase 2 trial for BMN-111 for achondroplasia
2H 2013: Potential initiation of Phase 3 trial for BMN-673 for solid tumors
4Q 2013: Potential FDA approval of GALNS for MPS IVA
http://investors.bmrn.com/releasedetail.cfm?ReleaseID=716410

Cowen and Co. analyst Phil Nadeau wrote in a research note via Reuters, "With an estimated 3,000 GALNS patients worldwide, we believe this represents a $500 million to $800 million opportunity for BioMarin."

He added, "Our consultants have said that given the unmet need in (the disorder), the FDA could approve the drug even if the statistics in the primary endpoint were missed."

Based on the above valuation, it means it would cost $166000 to -$266000 to the patient to generate 500-800 million which is outrages amount in any condition. Even Biomarin think it can generate 775 million in 2015.

Jacques Bienaime, CEO of BioMarin, said "the GALNS clinical program is currently the highest development priority at BioMarin, and this positive Phase 3 study serves as a potentially transformative milestone for the company."

"The positive results from this pivotal study will help support GALNS as the first therapy available to help the approximate 3,000 people worldwide suffering from MPS IVA -- a rare, degenerative, life-threatening genetic condition with no available therapy," commented Hank Fuchs Chief Medical Officer at BioMarin.

Through September 30, 2012, Biomarin had accumulated losses of approximately $486.4 million.

Dendreon Corp (DNDN) was at $45 stock and it fda approved Provenge cost $93k and its stock went down and now its trading at $4.17.

http://www.xconomy.com/seattle/2010/04/29/dendreon-sets-provenge-price-at-93000-says-only-2000-people-will-get-it-in-first-year/

Other Biomarin approved products are Naglazyme (galsulfase), Kuvan (sapropterin dihydrochloride), Firdapse (amifampridine phosphate) and Aldurazyme (laronidase) and 533 million in Cash. Its good for long term but at current price of $49.10, its a sell with Price Target of $40 and long term price target of 36.92

]]> Mon, 05 Nov 2012 20:43:06 -0500 http://www.freefdawatchlist.com/2012/11/bearish-call-on-bmrn-3k-patient.html

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the pivotal Phase 3 study of GALNS met the primary endpoint of change in six-minute walk distance compared with placebo at 24 weeks in subjects receiving weekly infusions of GALNS at the dose of 2 mg/kg (p=0.0174). MOR-004 was a randomized, double-blind, placebo-controlled study evaluating two doses of GALNS (BMN-110, N- acetylgalactosamine-6-sulfatase) for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. Morquio A syndrome is estimated to occur in 1 in 200,000 to 300,000 live births.

(click to enlarge)

The rate of incidence of MPS IVA is as yet unconfirmed and varies among different populations but estimates vary between 1 in 200,000 live births and 1 in 250,000 live births. The estimated prevalence is between 1,000 and 1,500 patients in the U.S., EU and Japan and between 1,500 to 2,000 patients in the rest of the world for a total of 2,500 to 3,000 patients.

http://investors.bmrn.com/releasedetail.cfm?ReleaseID=718462
Anticipated Upcoming Milestones for Biomarin

4Q 2012: Results for Phase 3 trial for GALNS for MPS IVA
4Q 2012: Update on Phase 1/2 trial for BMN-673 for solid tumors
1Q 2013: Market authorization application filing for GALNS for MPS IVA
1Q 2013: Results for Phase 1/2 trial for BMN-701 for Pompe disease
1H 2013: IND filing for BMN-190 for LINCL (Batten disease)
2Q 2013: Initiation of Phase 3 trial for PEG-PAL for PKU
2Q 2013: Results for PKU-016 Kuvan neurocognitive study
Mid 2013: Initiation of Phase 2 trial for BMN-111 for achondroplasia
2H 2013: Potential initiation of Phase 3 trial for BMN-673 for solid tumors
4Q 2013: Potential FDA approval of GALNS for MPS IVA
http://investors.bmrn.com/releasedetail.cfm?ReleaseID=716410

Cowen and Co. analyst Phil Nadeau wrote in a research note via Reuters, "With an estimated 3,000 GALNS patients worldwide, we believe this represents a $500 million to $800 million opportunity for BioMarin."

He added, "Our consultants have said that given the unmet need in (the disorder), the FDA could approve the drug even if the statistics in the primary endpoint were missed."

Based on the above valuation, it means it would cost $166000 to -$266000 to the patient to generate 500-800 million which is outrages amount in any condition. Even Biomarin think it can generate 775 million in 2015.

Jacques Bienaime, CEO of BioMarin, said "the GALNS clinical program is currently the highest development priority at BioMarin, and this positive Phase 3 study serves as a potentially transformative milestone for the company."

"The positive results from this pivotal study will help support GALNS as the first therapy available to help the approximate 3,000 people worldwide suffering from MPS IVA -- a rare, degenerative, life-threatening genetic condition with no available therapy," commented Hank Fuchs Chief Medical Officer at BioMarin.

Through September 30, 2012, Biomarin had accumulated losses of approximately $486.4 million.

Dendreon Corp (DNDN) was at $45 stock and it fda approved Provenge cost $93k and its stock went down and now its trading at $4.17.

http://www.xconomy.com/seattle/2010/04/29/dendreon-sets-provenge-price-at-93000-says-only-2000-people-will-get-it-in-first-year/

Other Biomarin approved products are Naglazyme (galsulfase), Kuvan (sapropterin dihydrochloride), Firdapse (amifampridine phosphate) and Aldurazyme (laronidase) and 533 million in Cash. Its good for long term but at current price of $49.10, its a sell with Price Target of $40 and long term price target of 36.92

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