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Re: wimike post# 29079

Thursday, 08/03/2017 5:37:23 AM

Thursday, August 03, 2017 5:37:23 AM

Post# of 38634
Remember this analysts quote Mike? It appears that the entire inherent costs to do all 3 categories of human abuse & liability studies according to Aschoff is only $1M to $1.5M.

And since we know that IPCI already completed the CAT 1 studies how much can the CAT 3 HAP study really cost?

So all's I'm saying is that the market overreaction to the Rexista adcom rejection is definitely not going to be this company's legacy and all we can do is let things play out and have faith that time is slowly but surely going to unlock value here and lots of it glty>>>

Aschoff wrote, “We estimate that the freedom to forego Phase 3 testing will shave off at least $20 million from the cost of development, as well as about 18-24 months of time. The NDA process should now only cost Intellipharmaceutics about $1-1.5 million. We believe that the FDA was satisfied with the bioequivalence data in the IND and thus what remains to be completed prior to NDA submission primarily involves six-month stability testing comparing bioequivalence before and after the six-month period.”



Never buy or sell based on my posts! My posts are just my opinion!