Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Even when I try to be nice...

So just like that you now believe this is BS?

After calling it zombie sequestox?

..somebody always walks by with a kick me sign on their back.





Let's review:

1. This was always BS in regards to Tmax delay being a safety issue. None of my posts say otherwise.

2. No one can say anything about what is possible or how SequestOx compares to other drugs without knowing the extent of the Tmax delay. There is no good reason not to have revealed this, other than it being out of range of approved drugs.

3. The pre-eminent component of the 505b2 FDA approval process is bioequivalence to the reference drug. Not having bioequivalence is a major risk for failure of any application for any kind of drug. Lack of bioequivalence means the application is at the mercy of FDA bureaucrats who spend all of their days thinking about Cmax, AUC, and Tmax, and who have a lot more to lose by approving a bad drug than by rejecting a good drug.

4. Lack of bioequivalence is material information.

5. Lack of bioequivalence is not properly conveyed in March 2014 PR.

6. Lack of bioequivalence was a specific concern of FDA, as evidenced by their request for Phase 3 bioequivalency trial. This concern was covered up by Nasrat Hakim by referring to this as a "labeling study."

7. Lack of bioequivalence due to Tmax delay in fed conditions is a specific reason for failure of this specific kind of drug. Again, this specific piece of information became material as of the Avridi adcom.

8. Knowing all of the above, a reasonable individual can surmise that Nasrat Hakim was not greatly surprised by either the lack of an AdCom or the CRL. Eugene Pfeiffer was brought in early and most likely was trying to work behind the scenes on behalf of SequestOx from the time he came on board.

9. Zombie SequestOx* is the nickname for a Dead Drug Walking. Appears alive but with a fatal wound. I believe this more contemporary reference to zombies has greater appeal for younger investors compared with the dated "naive ghost" analogy, such as Bruce Willis in Sixth Sense. ("I see dead drugs.")

10. Even with approval, if the drug's instructions scare away the prescribers, then it remains Zombie SequestOx*.

11. Any solution that involves tampering with tamper-proof capsules and sprinkling on apple sauce will effectively render this Dead Drug Walking. The Apple Asterisk on Zombie SequestOx* is the official graphical symbol of the asinine notion that any physicians would ever prescribe a drug with such silliness in the instructions.