Elite Pharmaceuticals Inc (ELTP)

[MR ELITE]

Glad to have you back brother couch

I am of the belief that we would have still got the CRL reason I say that is we had 483 observations that needed corrected. And there were three more but they all had to do with submission of sequestox.

But here's my question and hopefully someone can find the FDA guide lines or rules for it is once you start the submission of your 6 month PDFUA and the FDA comes in and inspect your facility can you go ahead and make your changes then to whatever compliances that they found that need corrected and if so can you you go ahead and start another study in that time frame or do you have to wait for a CRL to come out

Where I'm going with this is I believe we've known since early April that we had a label issue or a safety issue and that's why Eugene was brought in and during that timeframe we also fixed the 483 observations that were cited so I'm thinking you can fix observations and things of this nature under FDA guidelines but you can't run a new study until after you receive a CRL. Your thoughts and really glad your back