Mike Havrilla

Extreme FDA Trades: 30 Stocks Under 5 Bucks

JAV will be filing a NDA for Dyloject in the fall, which is already approved in Europe. The Ereska results are frustrating because of how close they were to being statistically significant so this one is up in the air whether or not a NDA will be filed.


On Aug 11 12:24 PM shave-tits wrote:

> Re: $JAV - Oh well, it happens to everyone I guess. Too bad you bought
> yesterday, and not today, you would have gained a larger qty of shares.
> Darn that crystal ball.
>
> Does this disappointing news about the trial results mean that their
> drugs will not be successful? Will they have to reengineer it, or
> do the rest results need more investigation to determine if something
> was tested wrong? How does this affect the future of $JAV, will it
> rebound, or is it viewed as a loser...?

Extreme FDA Trades: 30 Stocks Under 5 Bucks

Check out this good, recent update article for JAV:
seekingalpha.com/artic...

JAV also mentioned above in my extreme trade article for pending Ereska Phase 3 results:

Ereska is a non-opiate pain drug being developed by (1) Javelin Pharma (AMEX:JAV)($1.90) for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury).


On Aug 10 12:23 PM shave-tits wrote:

> hi mike I just got a twt that you're buying JAV, but it didn't say
> why... can you elaborate? is a testing trial due for reporting soon?

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?

FDA Decisions and Clinical Trials: An Updated Calendar

www.etfinnovators.com/...


On Feb 06 09:17 AM ArchDukeFerdinand wrote:

> You left out Arena Pharmaceuticals (seekingalpha.com/symbo...).
> They are suppose to get a FDA decision on their obesity drug lorcaserin
> in late March of this year.