Mike Havrilla

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.

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.

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