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 Calendar: 2H09 Binary Event Trades

BIEL stated in 6/19/09 PR they have about 720 million shares of stock outstanding, but stock price has still increased by over 700% in past month:
www.google.com/finance...

Stock Valuation -- There are currently approximately 720 million outstanding shares, which represent a total market capitalization of approximately $7.2 million.

finance.yahoo.com/news...



On Jul 27 10:30 PM Dan Weiss wrote:

> I would advise extreme caution on BIEL. In the first quarter of 2009
> alone (January-March) the company nearly doubled its shares outstanding
> from 266.9 million to 492.2 million with sales at 0.005 per share
> and I would not be shocked if significant additional shares were
> issued since then.

Looking for Laggards After the Latest Market Rally

Here is the rest of the article from my blog with a valuation comparison of HITK vs. CPD:

With shares of HITK trading up today by about 25% on record quarterly revenue of $25.1M and diluted net income of $1.1M or 9 cents per share, Caraco appears extremely undervalued at current levels of $3.50 per share. Caraco trades at the lowest price to sales ratio [PSR] in the generic drug industry at just 0.24X with a trailing price to earnings ratio [PE] of less than 4X, zero debt, $33.6M cash, and a market cap of $123M. As a comparison HITK trades at a PSR of 0.84X with an estimated forward PE of 16X, negligible debt, $16.1M cash, and a market cap of $71M.