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Tuesday, December 12, 2017 11:19:01 AM
Taking an objective critical view at this point may not sit well with many...but considering the current IPCI market cap at approximately $28M has this company priced for total and complete failure...it's time for someone at IPCI mgmt., IPCI's BOD's or IPCI's core shareholder base to at least provide Dr. Odidi with constructive criticism.
He may be a brilliant scientist but almost 9 years since taking IPCI public the dreams he set out to fulfill aren't being executed on a remotely timely basis and the window of opportunity is rapidly closing.
Next year is make or break time for IPCI and the CAT 3 HAP studies take 9 full months from the day they start. So even if they started on October 1st we're looking at next July 1st at the absolute earliest b4 IPCI's even in a position to submit the new oxy data to the FDA. So if Dr. Odidi is sticking to his new plan of taking IPCI's oxy all the way through the FDA approval process then seeking a plug and play partner...the earliest we can reasonably expect the FDA to even schedule another PDUFA date and adcom is sometime next summer or next fall...I really don't know how fast the FDA may move towards rescheduling a PDUFA date once they have the requested/required nasal and oral studies...but 9 months from October 1st is July 1st 2018...so it's sometime after that before we can expect any real progress being made on IPCI's oxy NDA candidate.
So hopefully there's some positives coming on the PODRAS or Regabatin front prior to next July because I don't think Pristiq and Lamictal FDA approvals are coming anytime soon and both those markets continue dwindling each and every year and Mallinkrodt sure isn't delivering many sales on SeroquelXR as they continue trying to sell their generics division.
It's hard to be optimistic/positive when we've got almost 9 years of results as our guide and just once I would love to have a reason provided by Dr. Odidi/IPCI for fresh optimism to return to this stock!
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