Mike Havrilla

FDA Calendar Updates: Still Waiting on BioDelivery Sciences

I am also very surprised by the lack of share price response on the FDA approval today for BDSI -- especially given the positive overall market action this week. There was already a price upgrade by Ladenburg to $9/share and Zacks expects $10 after FDA approval so the next catalysts for the stock will be clinical trial results for their remaining pipeline, US sales/royalties for Onsolosis, and EU approval/launch of Onsolis. Unless management says something amazing on the call tomorrow morning!

FDA Calendar Updates: BioDelivery Sciences Worth the Wait

The same as I wrote in this article and still long BDSI and waiting.


On Jul 07 04:53 PM wary wrote:

> Mike , could you give your current thoughts about BDSI ?

Pending FDA Decisions: 20 Extreme Trades

DSCO does not currently have a pending application at the FDA and has not provided an update yet following their meeting with the agency to discuss the latest CRL for Surfaxin:

WARRINGTON, Pa., May 11, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO - News) has received written notification from the U.S. Food and Drug Administration (FDA) that an end-of-review meeting has been scheduled for June 2, 2009 at the FDA offices in Rockville, Maryland. The purpose of this meeting is to determine the resolution of the remaining primary issue necessary for Discovery Labs to gain U.S. marketing approval of Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

On April 17, 2009, Discovery Labs received a Complete Response letter from the FDA for Surfaxin for RDS. In its letter, the FDA focused primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before Surfaxin can be approved. The FDA questioned whether the BAT can adequately distinguish change in Surfaxin drug product over time and whether Discovery Labs has adequately validated the BAT and determined its final acceptance criteria. Discovery Labs intends to rely on data already submitted to the FDA, as well as limited existing data, to support the comparability of Surfaxin clinical drug product to commercial Surfaxin drug product and demonstrate that the BAT can adequately distinguish change in Surfaxin over time and is an appropriate test for monitoring Surfaxin biological activity throughout shelf-life.

Following the meeting and receipt of formal written minutes from the FDA, Discovery Labs intends to provide an update regarding the outcome and anticipated timeline to potential approval of Surfaxin.



On Jun 24 01:40 PM thegoodking wrote:

> I see that DSCO(Discovery Labs) is missing in thhe list. Their drug
> is in its final stages and FDA is waiting on the quality test(seekingalpha.com/symbo...)
> which tests its shelf life.

FDA Calendar Updates: BDSI, SVNT Deadlines Approach

Approval on the way for BDSI's Onsolis:

RALEIGH, N.C., Jun 15, 2009 (BUSINESS WIRE) -- --FDA Action Forthcoming BioDelivery Sciences International, Inc. (BDSI) today announced that the company has reached agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the company's New Drug Application (NDA) for ONSOLIS(TM) (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its action date of last Friday for this NDA, the Division has informed the company that FDA will not be issuing a review extension letter as their action on the NDA is forthcoming. BDSI received a Complete Response letter from FDA on the NDA for ONSOLIS on August 28, 2008, with the only deficiency being the new requirement for a REMS. The REMS was not required at the time the NDA was originally submitted to FDA in October 2007. The REMS was formally submitted to the FDA on December 12, 2008 and the submission was placed under a six month review period. "FDA informed us on Friday that given how close they are to taking their action, they saw no need for issuing a review extension letter, which would have formally given them more time to complete their review. In other words, they simply need a little more time, which we believe is not inconsistent with other recent NDA approvals for other products at the Agency where a REMS was required for approval," stated Dr. Mark A. Sirgo, President and CEO of BioDelivery Sciences. "We view this as positive news, together with the fact that we have reached agreement with the reviewing division and the review team on all aspects of our NDA, including our REMS. Our dialog and working relationship with the reviewing division have been outstanding and have been fundamental to the progress we have made in working with them in this significant undertaking, to complete the first 'opioid' REMS and the first REMS for this Division. We look forward to FDA's forthcoming action," stated Dr. Sirgo. "Although we can not pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a first half 2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target." Dr. Sirgo continued, "As it relates to BDSI's current financial position, we are pleased to announce that over the last several weeks we have received funds from the exercise of certain outstanding warrants. The receipt of these funds alone should allow us to comfortably manage the company into the fourth quarter of this year, including the continued advancement of our pipeline, without any additional financing required."


On Jun 12 08:26 AM paultheprofit wrote:

> yet insider's JUST sold BDSI..Hmmm..
>
> 2009-06-05-
> -2009-06-08
> Sale 2009-06-09
> 5:26 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Finn Andrew L
>
> (Executive Vice President) 25,000 $6.75 $168,750 752,413
> (Direct) View
> 2009-06-05
> Sale 2009-06-09
> 5:25 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Sirgo Mark A
>
> (President and CEO
> Director) 30,000 $6.667 $200,000 808,175
> (Direct) View
> 2009-06-05
> Sale 2009-06-09
> 5:25 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI MCNULTY JAMES
> A
> (Chief Financial Officer) 20,000 $6.5 $130,000 39,371
> (Direct) View
> 2009-06-03-
> -2009-06-04
> Sale 2009-06-05
> 5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Sirgo Mark A
>
> (President and CEO
> Director) 20,000 $6.009 $120,182 838,175
> (Direct) View
> 2009-06-03-
> -2009-06-04
> Sale 2009-06-05
> 5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI MCNULTY JAMES
> A
> (Chief Financial Officer) 20,000 $6.009 $120,182 59,371
> (Direct) View
> 2009-06-03-
> -2009-06-04
> Sale 2009-06-05
> 5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Finn Andrew L
>
> (Executive Vice President) 25,000 $6.009 $150,227 777,413
> (Direct)

13 Extreme FDA Trades

Jimmy,

It doesn't matter, the small/micro-cap companies still tend to run-up going into their FDA decisions or panel meetings.

Mike


On Jun 03 01:32 PM jimmy46 wrote:

> Almost all these drugs are "ME TOO" drugs,
> copies of something already on the market and have little chance
> of being a big earner.
>
> The antibiotic by ADLS, I'm not familiar with, but assume it's a
> ME TOO also.
>
> One of the cancer drugs has so many restrictions that only a few
> hundred people a year would take it even if it's approved.
>
> That leaves one cancer drug that might, might, be a winner,
> but cancer drugs have a history of disappointing,
> so a roll at the craps table would probably be a more likely winner.

13 Extreme FDA Trades

Pete,

There is no need to hold the extreme FDA trade stocks thru their actual decision dates or advisory panel meetings -- you can take advantage of the run-up as the decision/meeting dates approach with very little risk and still nice upside.

Mike


On Jun 03 04:44 AM PeteK wrote:

> These are all Big Gambles indeed.
> But still better than going to the casinos.

13 Extreme FDA Trades

Steve,

DSCO has not provided any public update as of yet, but the stock is trading down about 8% today at the open.

Mike


On Jun 03 07:58 AM User 416278 wrote:

> Hi Mike,
>
> Thanks for the article. In your previous extreme trade article, DSCO
> was stated to have an end-of-review meeting on 2 June 09.
> I was wondering why wasn't there any price action on this stock?
>
>
> Thanks!
>
> Steve

12 Extreme FDA Trades on New Product Decisions

The upcoming FDA panel meeting will be key (6/2/09) and if it gets a positive review and rec for approval the stock could easily trade above your cost basis. However, the FDA has been tough on approving new antibiotics or even expanding the label of already approved anti-infectives over the past year so it makes for a high risk/reward trade going into the panel meeting.


On Apr 13 08:57 PM godfreta wrote:

> What do you think about adls. I have been holding now for three years.
> I am dying here. My cost average is about .69 cents. Ihave 50% of
> my savings in this company. I am physician and i CAN NOT IMAGINE
> it failing.

12 Extreme FDA Trades on New Product Decisions

CTIC did not submit the pixantrone NDA yet:
biomedreports.com/arti...


On Apr 09 06:36 PM Earl who likes seeking alpha wrote:

> You missed a major one in my opinion. CTIC, who you did mention,
> sold their share of Zevalin in order to help cashflow for the rest
> of the year. CTIC has pixantrone, a chemotherapy drug, which has
> the potential to exceed Rituximab (currently a $5 bil a year drug).

Trading FDA Decisions: 14 Candidates

check out this article for SVNT update:
seekingalpha.com/artic...




On Mar 16 02:18 PM truthiac wrote:

> You could add the PDUFA date of August 1, 2009, for Savient Pharmaceuticals,
> Inc.'s (seekingalpha.com/symbo...) pegloticase for treatment-failure
> gout. Since SVNT is a one-product candidate company, a major impact
> can be expected.

Trading FDA Decisions: Cypress Bioscience Soars, A Trio of Buys

K-Fine's strategy is to invest in biotech ETFs such as IBB + XBI in addition to companies such as DNA rather than trying to pick riskier small/micro-cap stocks, which is a reasonable strategy since she manages other people's money and has to invest a lot more capital than you & me trading online

Below is a link to my blog for the new healthcare indexes that I follow for investing/trading ideas:
www.etfinnovators.com/...

Also, I track the cos. with pending FDA or clinical trial decisions, including over 140 such ideas at the link below:
www.etfinnovators.com/...

Trading FDA Decisions: Cypress Bioscience Soars, A Trio of Buys

Jazz Pharma (JAZZ) is starting a 2nd Phase 3 trial for JZP-6 (sodium oxybate) Expected NDA Filing by EOY-09 + Phase 3 Results Expected Mid-09

Bio-Pharma, Diagnostics Buyout Binge Begins

Check out my other article today for JAV - also it is one of my nine stock picks for this year and included in those articles

I don't follow RPRX as closely, but it is included in the clinical trial calendar I just posted on my blog:
www.etfinnovators.com/...

Mike


On Jan 11 09:05 AM y3maxx wrote:

> Hi Mike,
>
> Great list to reference with.
>
> ...Repros Therapeutics (seekingalpha.com/symbo...) nor
> Javelin Pharmaceuticals (seekingalpha.com/symbo...) don't
> seem to appear on any list.
>
> Repros is in new 52 week high territory with two drugs in late stage
> development and Javelin has two Ph3 pain drugs in development. <br/>
>
> Both have cash, no debt with overhead costs controlled stringently.
>
>
> tia

Potential Short Trades on Pending FDA Decisions

Good chance to pick up some shares of Cypress Bio today - I bought some around $5.40 - looks like the delay will be minor as FDA expects to decide in a "matter of weeks"

Potential Short Trades on Pending FDA Decisions

You missed the point of the article which is developing a short ETF for the entire group of companies with pending FDA decisions since they tend to underperform their benchmark funds as a GROUP - I have already written positively about CYPB, but it is only one company in the entire group
:
seekingalpha.com/artic...