KV Pharmaceutical: FDA Issues New Update On Makena [View article]
what is the process to returning another products to market that you have posted long ago? and kva said it is expecting this happening between Aprile2012 to Sept.2012. Do you have any information about this?
12 Healthcare Companies Expecting May Catalysts [View article]
ALXA will get approved. 1. FDA released the negative brief info before panel vote. This was treated as a second CRL and management wisely took action after positive vote to re submit the risk management proposed by FDA.
2. FDA then issue a 3 months extension. Importantly the 3 months extension is a priority view time from FDA view definition. The 3 months priority view represents chance of 75 % to get approval based on the past experience. Let me just name some cases: SOMX (3 months approved), KV.A(3 months early approved), TSPT(3 months approved), and MNKD(3 months failed). **********************...
1. If the FDA felt like Adasuve was too dangerous, they would not have bothered with suggesting their own REMS. From what I've read, the FDA will delay its decision if a company turns in a REMS within 3 months of a decision date. ALXA already had its own REMS turned in well before the scheduled February decision. BUT once the advisory committee voted in favor of FDA's REMS in December, I believe ALXA removed its REMS and submitted the FDA's REMS (which is within the 3 months of the February FDA decision, and is why they delayed). VVUS is going through the same FDA delay due to REMS. Interesting information somebody gathered up on a thread at the Fool:
"I started researching how many times in the past has the FDA extended the PDUFA date so that they could conduct a thorough review of REMS submitted by the new drug sponsor. I have found the following new drug sponsor(s) and their respective new drug received a similar delay as did Vivus - Qnexa. Here is each New Drug - Sponsor(s): (1) Vandetanib - AstraZeneca (2) Tysabri - Biogen & Elan (3) Ampyra - Acorda Therapeutics (4) Abstral - Orexo & Prostraken Group (5) Ezogabine - GlaxoSmithKline & Valeant Pharmaceutical (6) Acthar - QuestCor In all 6 of these cases when the FDA extended or delayed the PDUFA date in order to review REMS, all 6 of these drugs were approved by the FDA. As you know, the relatively new REMS regulations, which gave the FDA much broader powers, were enacted in late 2007, and these rules became effective in 2008. I looked at the past history of delayed PDUFA dates, from 2008 to present, to try and find 1 new drug where the FDA extended or delayed the PDUFA date solely for the reason of reviewing the REMS submitted by the new drug sponsor. I have not found 1 example of where the new drug was not approved by the FDA. The 2 examples you gave of PDUFA dates that were delayed and the new drug was not approved are: Cladribine (Merck) and Horizant (XenoPort & GlaxoSmithKline). However, Cladribine was delayed due to the FDA needing more time for a full review of additional information provided under Merck's new drug application (NDA). The Cladrbine press release did not indicate that this information was REMS or REMS related. Horizant (XenoPort & GlaxoSmithKline) was delayed due the FDA needing more time to review the REMS that was submitted by the drug sponsors. Horizant was approved by the FDA." http://bit.ly/xoDVk8... ======================... Originally filed for multiple dose, FDA panel recommended single dose, 3 month wait requested, assuming approval comes Friday it will be for single dose of ADASUVE in a 24 hour period. That's how i read the Psychopharmacologic Drugs Advisory Committee recommendation. What matters is that the drug advisory panel recommended ADASUVE approval with the revised dosing guidelines. Someone noted at the end of the seekalpha article that the same 3 month wait period happened to SOMX, KV.A and TSPT - all resulted in modified dosing and approval by FDA when they came up for review. So the working theory here is that the additional 3 months requested by the FDA was sufficient to review Psychopharmacologic Drugs Advisory Committee recommendation for Alexa's ADASUVE Approval with revised dosing guidelines. Hopefully we have a winner here, the upside will be tremendous! ======================...
Pivotal FDA Decision Upcoming For Alexza [View article]
Hi Jason all others, I have a guess that the approval will issued and a BOLD guess that it may come out some days as early than May 4th. Reasons are as follows:
1. FDA released the negative brief info before panel vote. This was treated as a second CRL and management wisely took action after positive vote to re submit the risk management proposed by FDA.
2. FDA then issue a 3 months extension. Importantly the 3 months extension is a priority view time from FDA view definition. The 3 months priority view represents chance of 75 % to get approval based on the past experience. Let me just name some cases: SOMX (3 months approved), KV.A(3 months early approved), TSPT(3 months approved), and MNKD(3 months failed).
Biotech-Focused Star Hedge Fund Tang Capital's Q1 2012 Picks In Its $429 Million Portfolio [View article]
I have a guess that the approval will issued and a BOLD guess that it may come out some days as early than May 4th. Reasons are as follows:
1. FDA released the negative brief info before panel vote. This was treated as a second CRL and management wisely took action after positive vote to re submit the risk management proposed by FDA.
2. FDA then issue a 3 months extension. Importantly the 3 months extension is a priority view time from FDA view definition. The 3 months priority view represents chance of 75 % to get approval based on the past experience. Let me just name some cases: SOMX (3 months approved), KV.A(3 months early approved), TSPT(3 months approved), and MNKD(3 months failed).
Apricus Biosciences' Promising Pipeline Points To A Bright Future [View article]
Well, the drop of APRI was not suprising after its stock offer. The deeper it drops, the higher it will be up. If it does have big and good news recently, it will further be slipping . If you looked at the 3 years charts, it had two previous low at $1.8 and $2.1. These two lows could be the indication of stopping slip(suppose it has now news come out). The stock market is as such game. Once it reaches the resistence level, the short and MM will come back and its price will go up again. It may be in another 1-2 months time for turning around
2 Potentially Solid Transdermal Drug Biotechs With Catalysts For 2012 [View article]
Apri began slipping after its stock offer. I will continue slip until it finds its resistant points. Not sure where is the resistant level now, but once it reaches to this level, it will be up again.
With Libigel A Failure, Where Will Biosante Bottom Out? [View article]
I really do not understand that you bet one the phase 3 result in the first phase 3 trial. You can only bet the pahse 3 re trial outcome for the second time when FDA request company to re do phase 3 test on the condition that the first phase 3 test is very positive, but still FDA turned it down for some reasons.
Transcept Wins FDA OK For Insomnia Drug, What's Next? [View article]
TO Bert: thanks for your article. i do not stand in the short side for TSPT. The technical chart and background between TSPT and SOMX are very much different. 1. for SOMX, it took almost 5 months after FDA approval finding a partner, Procter & Gamble. Why did not it find a partner before the FDA approval, there should be some reasons for this. 2. for TSPT, it signed collaboration agreement with Purdue before approval. Purdue will likely to enter into the agreement that could tiger milestone payment of $10 -20 M payment.
the share price on TSPT should be standing above $10 when Purdue announces the collaboration agreement in the short term.
End Of Year Fireworks For The Biotech Sector [View article]
TSPT predicate: 1. 99% chance of FDA approval on or one day before Nov. 27, 2011 2. its price will be around $12- $14 on the news released. believe or not, just wait to see...
WBB Securities Recommends Alexza Pharmaceuticals As A Strong Buy [View article]
KV Pharmaceutical: FDA Issues New Update On Makena [View article]
Do you have any information about this?
Pivotal FDA Decision Upcoming For Alexza [View article]
The class 1 review should be 2 months (60 days) as per FDA reviewing defination.
Thanks
12 Healthcare Companies Expecting May Catalysts [View article]
1. FDA released the negative brief info before panel vote. This was treated as a second CRL and management wisely took action after positive vote to re submit the risk management proposed by FDA.
2. FDA then issue a 3 months extension. Importantly the 3 months extension is a priority view time from FDA view definition. The 3 months priority view represents chance of 75 % to get approval based on the past experience. Let me just name some cases: SOMX (3 months approved), KV.A(3 months early approved), TSPT(3 months approved), and MNKD(3 months failed).
**********************...
1. If the FDA felt like Adasuve was too dangerous, they would not have bothered with suggesting their own REMS. From what I've read, the FDA will delay its decision if a company turns in a REMS within 3 months of a decision date. ALXA already had its own REMS turned in well before the scheduled February decision. BUT once the advisory committee voted in favor of FDA's REMS in December, I believe ALXA removed its REMS and submitted the FDA's REMS (which is within the 3 months of the February FDA decision, and is why they delayed).
VVUS is going through the same FDA delay due to REMS. Interesting information somebody gathered up on a thread at the Fool:
"I started researching how many times in the past has the FDA extended the PDUFA date so that they could conduct a thorough review of REMS submitted by the new drug sponsor.
I have found the following new drug sponsor(s) and their respective new drug received a similar delay as did Vivus - Qnexa. Here is each New Drug - Sponsor(s):
(1) Vandetanib - AstraZeneca
(2) Tysabri - Biogen & Elan
(3) Ampyra - Acorda Therapeutics
(4) Abstral - Orexo & Prostraken Group
(5) Ezogabine - GlaxoSmithKline & Valeant Pharmaceutical
(6) Acthar - QuestCor
In all 6 of these cases when the FDA extended or delayed the PDUFA date in order to review REMS, all 6 of these drugs were approved by the FDA.
As you know, the relatively new REMS regulations, which gave the FDA much broader powers, were enacted in late 2007, and these rules became effective in 2008. I looked at the past history of delayed PDUFA dates, from 2008 to present, to try and find 1 new drug where the FDA extended or delayed the PDUFA date solely for the reason of reviewing the REMS submitted by the new drug sponsor. I have not found 1 example of where the new drug was not approved by the FDA.
The 2 examples you gave of PDUFA dates that were delayed and the new drug was not approved are: Cladribine (Merck) and Horizant (XenoPort & GlaxoSmithKline). However, Cladribine was delayed due to the FDA needing more time for a full review of additional information provided under Merck's new drug application (NDA). The Cladrbine press release did not indicate that this information was REMS or REMS related.
Horizant (XenoPort & GlaxoSmithKline) was delayed due the FDA needing more time to review the REMS that was submitted by the drug sponsors. Horizant was approved by the FDA."
http://bit.ly/xoDVk8...
======================...
Originally filed for multiple dose, FDA panel recommended single dose, 3 month wait requested, assuming approval comes Friday it will be for single dose of ADASUVE in a 24 hour period. That's how i read the Psychopharmacologic Drugs Advisory Committee recommendation.
What matters is that the drug advisory panel recommended ADASUVE approval with the revised dosing guidelines. Someone noted at the end of the seekalpha article that the same 3 month wait period happened to SOMX, KV.A and TSPT - all resulted in modified dosing and approval by FDA when they came up for review. So the working theory here is that the additional 3 months requested by the FDA was sufficient to review Psychopharmacologic Drugs Advisory Committee recommendation for Alexa's ADASUVE Approval with revised dosing guidelines.
Hopefully we have a winner here, the upside will be tremendous!
======================...
Pivotal FDA Decision Upcoming For Alexza [View article]
I have a guess that the approval will issued and a BOLD guess that it may come out some days as early than May 4th. Reasons are as follows:
1. FDA released the negative brief info before panel vote. This was treated as a second CRL and management wisely took action after positive vote to re submit the risk management proposed by FDA.
2. FDA then issue a 3 months extension. Importantly the 3 months extension is a priority view time from FDA view definition. The 3 months priority view represents chance of 75 % to get approval based on the past experience. Let me just name some cases: SOMX (3 months approved), KV.A(3 months early approved), TSPT(3 months approved), and MNKD(3 months failed).
Biotech-Focused Star Hedge Fund Tang Capital's Q1 2012 Picks In Its $429 Million Portfolio [View article]
1. FDA released the negative brief info before panel vote. This was treated as a second CRL and management wisely took action after positive vote to re submit the risk management proposed by FDA.
2. FDA then issue a 3 months extension. Importantly the 3 months extension is a priority view time from FDA view definition. The 3 months priority view represents chance of 75 % to get approval based on the past experience. Let me just name some cases: SOMX (3 months approved), KV.A(3 months early approved), TSPT(3 months approved), and MNKD(3 months failed).
Apricus Biosciences' Promising Pipeline Points To A Bright Future [View article]
2 Potentially Solid Transdermal Drug Biotechs With Catalysts For 2012 [View article]
With Libigel A Failure, Where Will Biosante Bottom Out? [View article]
5 Healthcare Stocks Under $5 Poised To Rise [View article]
Transcept Wins FDA OK For Insomnia Drug, What's Next? [View article]
5 Companies Awaiting FDA Approval Decisions In Q1 2012 [View article]
Transcept Wins FDA OK For Insomnia Drug, What's Next? [View article]
thanks for your article.
i do not stand in the short side for TSPT. The technical chart and background between TSPT and SOMX are very much different.
1. for SOMX, it took almost 5 months after FDA approval finding a partner, Procter & Gamble. Why did not it find a partner before the FDA approval, there should be some reasons for this.
2. for TSPT, it signed collaboration agreement with Purdue before approval. Purdue will likely to enter into the agreement that could tiger milestone payment of $10 -20 M payment.
the share price on TSPT should be standing above $10 when Purdue announces the collaboration agreement in the short term.
End Of Year Fireworks For The Biotech Sector [View article]
1. 99% chance of FDA approval on or one day before Nov. 27, 2011
2. its price will be around $12- $14 on the news released.
believe or not, just wait to see...
KV Pharmaceutical: Surging Revenue and New Product Launch May Signal Turnaround [View article]
How do think kv's earning report? Will this report impact kv's share price trend?
thanks