Intellipharmaceutics International Inc. (IPCI)

[Samsa]

Numbers....you make a valid argument. I can not disagree with any statement you made. The only thing that does not make sense then is,the FDA's acceptance of the application and classifying it as substantially complete. One would have thought they had communication with the FDA all through the process and the FDA gave guidance as to what they would expect. Which tends to make one think the FDA was ok with going with 1 route of abuse labeling now and then following that up with the others.

BUT, just like Remoxy, did they not get direction from the FDA prior as well? IT makes me wonder if the FDA goes down one oath, telling the companies one thing. Then when the rubber hits the pavement and someone else gets the application they have a different opinion and then different direction? I really can't tell here.

As a side note,a question regarding a CRL. if one is given, is that like a denial and the company must resubmit the application all over again as if its new? if so that would be an extra added expense as we only qualify for the waiver one time. If we have to submit a new application we would not be entitled to the waiver. That would add an extra 1.7 million to our estimates on top of costs of studies.