Mike Havrilla

FDA Extreme Trades: 16 Stocks Under 5 Bucks

APPY needs to submit a 510k to the FDA since all of the companies in this article have pending decisions.


On Jun 28 11:46 PM Kenneth Franklin wrote:

> Mike,
>
> While you have some good companies in this list, I think you left
> out one with an extremely high potential both near term and long
> term. APPY - Aspenbio Pharma not only has a top notch diagnostic,
> AppyScore, which detects appendicitis, but also a top notch management
> team led by Daryl Faulkner.
>
> Being a trained statistician, I believe this company has been far
> oversold given the results reported in January. Initial studies had
> shown AppyScore to return about a 95% NPV while the results in January
> came out to be about 85% NPV. Two things have been discovered since
> those results; when combining AppyScore with a standard white blood
> cell count the NPV shot back to the high 90th percentil range. Secondly,
> the most recent trials had a far higher percentage of subjects with
> only mild appendicitis which would explain the disparity in results.
>
>
> Since AppyScore would be a first in class diagnostic, there is really
> no other competition on the market. My rough calculations lead me
> to believe that it could attain peak sales of nearly $1 Billion.
> Would you agree with this ballpark figure?

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