Replies to post #218388 on Elite Pharmaceuticals Inc (ELTP)

[RLSJ84]

Questions are.....

Does the FDA require a new BE study with fatty meal and sprinkling?

If so how quickly can elite accomplish this BE and include a packaged "response" presentation or data to the FDA.

Does this fall into class 1 because of the additional data that would supplement original data.

Hence why I have stated even with another BE this could be done with an approval by years end.

[pte]

Great posts on CRLs. I'll bet Eugene is more than familiar with these. My guess is he has a game plan in the works as we speak. Worst case if he can't make it happen he knows someone who can.

[Drugdoctor]

Nice DD there Couch... A lot of questions I had about the process were answered...

[Gman24]

Camargo huh..!!!... Nice DD Couch as always. Down but not out..!!!