Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

FDA FLAG LEVELS PAIN THERAPEUTICS STOCK

-"Pain Therapeutics stock is down 13.7% at $8.01 -- set for its worst day since May 2017 -- after the Food and Drug Administration (FDA) flagged an opioid-abuse risks in a review for the the company's pain drug, Remoxy."


From Yahoo Message Board

1 - FDA is now requiring applicants to prove Excipient Safety when administered by unintended routes. For example, previous Adcoms had concerns on polymers or dyes being injected. PTIE has a consultant presenting toxicology studies. (Biggest risk since we don't know the exact formulation)

2 - PTIE is not seeking oral label because 2 out of 4 endpoints met and I still think they get a majority split decision if they vote on this route. Should be no issue if they get a no vote since they are not seeking this label.

3 - Overall nasal and solvent data appears solid. I will take a second pass later. Smoking irritants - can this be a safety issue...smoking is hazardous to your health so i didn't see a specific vote on smoking label, it would be hard to say anything smoked is good.

Pain not expecting an approval after Remoxy documents posted this morning???!!!!!!