Replies to post #19592 on Intellipharmaceutics International Inc. (IPCI)

[Sparky77]

So what's the verdict numbers???
Samsa, you have any onsite on this??

[mopar44o]

Are we still waiting for TEVA to launch the other strengths of Focilian XR or is it done already? Are we just waiting on the new bioequivalence?

(I)Failure to market.—The first applicant fails to market the drug by the later of—

(aa) the earlier of the date that is—

(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or

[fabius]

Numbers, that could be a very welcome surprise; getting a final approval for Seroquel by november ?
would make IPCI profitable virtually overnight.

I would love to see the big catalysts hitting when we already have a 4/5$ per share.

Plus the more IPCI achieve and the more the hidden value of the company starts to sriface to everybody; 1bln mkt cap could likely be considered as reasonable to reach in the next 12months

[Samsa]

Numbers &Sparky....to answer your question the decision under (bb) does not have to be favorable or unfavorable. AA just states what starts the clock is "a court enters a final decision from which no appeal ( a court enters a final decision from which no appeal )" BB is final decree finding the patent was not infringed and CC is withdraw of the patent information by the applicant. Understand what (bb) is set up for. a first filer has had one of these happen and received a final approval and still fails to launch then under these sections the application who has a tentative can apply for final approval. the other time one can terminate the exclusivity is failure to launch after 75 days of approval. now just keep in mind its still not automatic ! we just had this happen with Focalin and the additional doses when Teva failed to launch to hold up IPCI's additional doses. once you believe a competitor has abandoned their 180 day exclusivity you are still sitting with a tentative approval. you must still go back to the FDA are request a final approval under one of those sections and basically say "hey, so and so failed to launch within the time frame can we have final approval" and we all know how that goes. hope that helps clarify