Replies to post #29489 on Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

Angelo- Are you saying that the oral and nasal HAP tests might have already been run on Rexista but the FDA has not had time to review the data on this yet?

No... not at all.

Actually since IPCI said they would do those tests... then I assume that they have not been done.

What I am saying is that the FDA liaison said something like "assume" or "make believe" or "suppose" that those tests have already been done... and what it seemed to me was that she was implying that the FDA was not concerned about the Oral and Nasal tests and was interested in the panel's opinion ONLY AS FAR AS THE RESULTS OF THE IV TEST RESULTS.

Also... the application didn't just happen in a black hole... there was constant communication between IPCI and the FDA as to what was needed... and if oral and nasal tests were required for approval... why did the FDA "accept" the submission... the whole purpose of the 2 months towards acceptance is to ascertain that all the information packets required for approval are included... why would the FDA accept an incomplete application???

The possibility is there, that because most (90%???) of the abuse is through IV use... then perhaps the FDA said OK let's get it on the market with a IV ADF label ASAP since it is a superior profile... and then we will work on the other aspects.

The questions the FDA asked of the panel specifically stated, if not stressed was... suitability "in regards to intra-venous use"... WHY???

I am not implying I think the FDA is likely to grant tentative approval on September 26th... but to deny that there is any possibility is... I believe... simply... ASININE.