Replies to post #219452 on Elite Pharmaceuticals Inc (ELTP)

[toybaby]

OK but it isn't rejected either !!! RIGHT ??

[lasers]

Totally wrong. A complete oversight by the FDA. The FDA made no mention of the successful 163 personPhase 3 with ZERO adverse safety events. That is exactly what the $ELTP mgmt will be emphasizing in their ongoing discussions with the FDA

Best re-listen to Nasrat CC and re-reading the transcript.

Say can you tell us what Nasrat said about the (1) labeling and (2)
the successful 163 personPhase 3 with ZERO adverse safety events.

[elichen]

"The FDA had all of this information about SequestOx and they still sent Elite" a $2.5 waiver of application fee and a priority review!!!

"Safety issue" (T-max) for SequestOx is exactly the same as for all other IR opioids! Simple labeling instructions take care of that issue just like on all other IR opioids "Take 1 hour before a meal or 2 hours after a meal". Can add "Do not exceed 2 caps within 4 hours" (or whatever the correct amount is, i am not certain).

In addition, while waiting for the FDA to approve SequestOx (which it will), there is CHINA! It could be approved in China regardless of status in USA. HUGE market.

Our guy Eugene has won his case many many times before and he will do so this time as well! ELTP WILL PREVAIL!