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Wednesday, August 08, 2018 8:31:05 AM
The difference is, Odidi can be replaced, we still have promise in a nice pipeline. EGLT does not have much else going for it.
EGLT's "Guardian" ADF tech is the exact same thing as IPCI's nPODS. They both are cheap clones of OxyContin, and they both use compressed polyethylene oxide (PEO) to form a hard shell. The difference is that Guardian tech has been proven adequate to receive IV and snorting ADF labels, while nPODS has not. EGLT's Arymo ER (morphine) is FDA approved and qualifies for snorting and IV abuse label. Like all other PEO-based drugs, it did not qualify for chewing label. EGLT pipeline includes similar versions of oxycodone and hydrocodone. Rexista (oxycodone) has never completed snorting or chewing studies, but it was described by Dr. Odidi as being able to be chewed "like bubblegum." Rexista, like all PEO-based drugs, will not qualify for the chewing label. Since Collegium's Xtampza oxycodone DOES have the chewing ADF label, Rexista will never be approved as an NDA. It should be pulled and re-submitted as generic OxyContin. It could get approval through the ANDA pathway, since OxyContin does not have chewing label.
What is nice about IPCI's pipeline? Regabatin is commercially worthless as an NDA. Pregabalin CR will be a very lucrative ANDA for multiple companies, but it will be a total dud as NDA. Same deal. Scrap the 505b2 NDA and submit ANDA for generic Lyrica CR. And PODRAS, as I have extensively proven, is nothing more than a grift. I don't disagree with you, Samsa, that EGLT doesn't have much going for it. But it has a hell of a lot more going for it than IPCI. IPCI has been shooting blanks, and the gun is empty. There is nothing that is publicly-known that will save this co from BK.
IPCI's pipeline is just a sad pipe dream.
Call on God but row away from the rocks.
-Hunter S. Thompson
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