Elite Pharmaceuticals Inc (ELTP)

[namtae]

Another loser so far

What's the story on this stock?

As I warned, ELTPs flagship product Sequest, anti-abuse IR opiate, did not receive FDA approval on or before July 14th as many believed and guaranteed

The FDA responded with a CRL stating it could not approve Sequest (the product), citing SAFETY ISSUES among other things.

Consequently, the shares of ELTP fell from 39 cents to 15 cents on heavy volume, settling around 19, trimming off about $140m of wildly over valued market cap.

So now the discussion centers around the fix necessary, if any, for Sequest to resubmit to the FDA. Precedent exits with drug Avridi which clearly indicates the safety problems with Sequest have already been addressed and rejected by the FDA AdCom by a 23-1 vote.

The major source of funding for ELTP has been a toxic ELOC through Lincoln Park, which further suggests ELTP has been unable to attract investment banking or PE capital. It is my understanding this failure is due to ELTPs science not withstanding scrutiny.

Obviously, that DD appears to have been correct