Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

"Tentative Approval"

Weezuhl- You are twisting what I said. The only thing that was conveyed was that there was misinformation and confusion on the boards regarding the manufacturer being listed on the application. IPCI's position is that that they do not need to specify the manufacturer. If Rexista were to be approved with no manufacturer listed on the NDA, a tentative approval would be granted.

Either IPCI used the phrase "Tentative Approval" or it was added by the poster. If IPCI is now using the phrase "Tentative Approval" while discussing the Rexista NDA, then that is news. These companies are very careful about the words they use. Find any other examples of companies using the phrase "Tentative Approval" when discussing their pending NDA.

I received clarification from IPCI in regards to specifying the manufacturer on Rexista NDA. Their position is they do not need to list a manufacturer to receive tentative approval. However, to receive final approval they need to specify the manufacturer.