Replies to post #219453 on Elite Pharmaceuticals Inc (ELTP)

[namtae]

Sequest seems to be rejected.. The FDA cannot approve it, therefore its failed their review. If Elite published their data, the problems may have been pointed out ahead of filing the NDA. Then again, maybe thats why they didnt publish

What are the chances Sequest can remedy the SAFETY ISSUES pointed out by the FDA? According to Nasrat (at least what he's allowed us to know) Sequest, the abuse deterrent, could actually lead to OVER DOSING and labeling cannot fix this problem..

So, whats left? A new trial with SPRINKLES, APPLESAUCE & Opening Tamper Proof Capsules with Labeling a mile long??

[IB_]

SequestOx NOT being approved would be a form of rejection I would say ...... The FDA did not say rejected but "not approved" puts us in a situation of not being allowed to sell SequestOx just as a "rejection" would !!!

I'm not saying that there is no hope for SequestOx but I think the chances for approval are much less than they were 6 months ago .............

IB_

[NASDAQ2020]

One last box to check off.

[Couch]

100% correct - a CRL is not a rejection letter. It includes suggestions via the FDA to help Elite get SequestOx approved.