Replies to post #21881 on Intellipharmaceutics International Inc. (IPCI)

[Tekterra]

I wanted to add, the NDA filing isn't just about getting a drug approved it's safe to use. It's also about getting FDA ok to market it and lable it. Manufacturing is part of the approval process to my understanding. If IPCI isn't manufacturing it on their own, they have a partner doing it for them. Without this finalized, FDA won't approve Rexista and can't continue further.

We all know IPCI don't market their own products, so it makes no sense if they are just finding a manufacturer to make the drug without selling it. Naturally, they have to have a manufacturer selected and is able to help them sell the drug. I just don't know the hold ups and what they are planning exactly.

[Samsa]

Tekterra....I have said all along I believe they already have one lined up. My personal opinion at this point is they have a final best offer with a non refundable payment thats payable upon acceptance. I believe they accept that agreement after they get accepted.

Your undertsanding is correct, they must announce and file the manufacturer site before their final approval or risk rejection. so Its just when they decide to announce at this point in my mind.

as for Podras, I'm glad you agree with my logic. It just makes sense. I'm not saying I am right, but It surely is plausible to go down the way I laid out. especially knowing they only filed one IND and Podras was discussed and granted fast track out of it. it then also makes sense as to why they held up filing until they knew Podras was granted or going to be. so they could include in the agreement. and it makes more sense to go after Podras as an NDA-s rather than starting over from scratch.

But I respect those that disagree. I surly can not claim to know for sure. but I can say the way I laid it out would be legal.