Thursday, June 28, 2018 9:33:52 AM
Now, how can a simple new offering+RS be considered as a proof to remain compliant for the following year ?
IPCI already asked for an extension, so they need to come up with something more than what did a few months ago (the last offering) and resulted in not being compliant in a matter of time.
I am not dreaming of magic accomplishments, since Odidi has a tremendous record of disappoiments, errors and lack of vision. I am just only hoping he understands he is at a verge of loosing his company ...for the cheap. Will he ?
PS
Concerning the PTIE AdComm result, it really seems to me that FDA is not likely to approve a new drug which has less abuse deterrence attributes than what is already on the market, which is COLL drug. If IPCI is not going to be as good as COLL we are going to be rejected again. Hope our magic BoD will spend some time in analyzing the Remoxy outcome.
Bottom line...we better have somthing big already in place before we go into a new AdComm ...UNLESS we go there already partnered with PURDUE (pure fantasy speculation)...because they know how to facilitate a favaourable outcome.
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