Friday, February 03, 2017 3:38:35 AM
With the acceptance letter for Rexista the chances are now high that IPCI can go the same way with Regabatin: prove bioquivalence and file a NDA. THAT is something no one here seems to see at the moment.
Regabatin has a potential market of $4 bn!! If Rexista gets approved in September, we should see additional value built in for Regabatin as it might come to the market also much faster!
Remember the words of the CFO:
"Once we have filed Rexista™, we will redirect our focus to our second NDA product candidate Regabatin™, which is our "once daily" formulation of Lyrica® (pregabalin). We believe this novel once-a-day formulation can enhance clinical outcomes for certain indications like fibromyalgia. The continued development program on Regabatin™ will require significant funding, and we are looking at funding options, which includes potential partnering opportunities."
"The company has a wealth of talent in developing complex extended-release drug delivery systems with abuse-deterrent properties, which we intend to demonstrate with Rexista™. But it doesn't stop there. Next in line is the continued development of our Paradoxical OverDose Resistance Activating System (PODRAS™) overdose prevention technology. We intend to enhance Rexista™ with our PODRAS™ delivery technology, which is designed to prevent overdose when more pills than prescribed are deliberately or inadvertently swallowed. In this case, PODRAS™ causes the amount of drug released over an extended period to be substantially less than expected.
While we believe ADF technology has an important role to play, the bigger problem facing society is that of opioid overdose, which leads to approximately 17,000 deaths annually in the U.S. We intend to advance PODRAS™ as a breakthrough technology in the area of overdose prevention.
And, as previously mentioned, we want to fund the development work on our Regabatin™ NDA product candidate to meet an unmet need in providing a once-daily formulation of pregabalin."
https://www.streetwisereports.com/pub/na/dialing-back-euphoria-the-intellipharmaceutics-solution-to-opioid-abuse
So while we'll get partner news for Rexista for sure within a short period (maybe PODRAS included), we might also hear about Regabatin in the weeks to come.
I feel we have finally reached a new chapter and I'm sure we'll leave the station now for a bright future.
cysonic
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