Replies to post #220171 on Elite Pharmaceuticals Inc (ELTP)

[toybaby]

Does that bring us into November, if all goes as stated~~

[dr_lowenstein]

Based on the FDA guidelines for resubmissions, it appears that SequestOx will be a Class 1 resubmission.

There is no basis for that conclusion. There could well be the need for another study and resubmission of that data which would likely result in a Class 2 determination. There could be the need for a reformulation of SecretOX which would likely result in a withdrawl of the application. thanks though

[namtae]

This is likely incorrect

Based on the FDA guidelines for resubmissions, it appears that SequestOx will be a Class 1 resubmission.

When analyzing which class category Sequest would fall under, its imperative to understand the FDA guidelines thoroughly to avoid mistakes

The evidence is clear and decisive, born of past practice by the FDA, Elite will receive approval for SequestOx on or before July 14th (three days hence) AND WITH THE ALL-IMPORTANT ADF LABEL.