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Re: Samsa post# 17758

Wednesday, 09/21/2016 4:56:59 PM

Wednesday, September 21, 2016 4:56:59 PM

Post# of 38634
FALSE: "PODRAS is already part of the formula in Rexista."




Not only is PODRAS not currently in the formula, it's not even currently a real thing. It's an idea which has been patented. The extensive clinical trial & error to get it to work will take multiple years and more likely than not will never work. Functional or not, it'll cost $25-50 million, maybe more, to figure out. Acura is working on very similar concept. They're multiple years ahead of IPCI, they have funding, and they have an actual research staff-- none of which IPCI currently has. Here's what Bob Jones said in a recent conference call about how much progress they've made in TWO YEARS:


In April we announced results of cohort one from study 400 which demonstrated that a three tablet dose of one of our test formulations LTX-04P lowered the relative maximum blood level of hydromorphone by approximately 22% compared to a non abuse deterrent version. This result exhibited the ability of LIMITX technology to retard the release of active ingredient when multiple tablets are ingested and makes it a viable abuse deterrent platform. The one and two tablet doses of LTX-04P did not deliver the active drug as we would expect for an immediate release dosage form which will require us to reformulate the microparticles in tablets that contain the active drug.





Okay, so after 2 years, Acura's most promising compound, the one they felt most deserved human study, does not work as designed if you take 1 or 2 tablets and gives 22% reduction if you take 3. It may be proof of concept, but it also shows they have very far to go. Every tweak they do will require a new human study- very slow and very expensive. But somehow, with no time, no money, and no research staff, IPCI has perfected PODRAS and even already has it incorporated into the Rexista nPODDDs formula, which, of course, they do not plan to tell anyone about. And, also, this is the reason for the three quarter delay on the NDA application.


Pure fantasy. More like delirium. Seriously, how is it possible to have such a fundamental misunderstanding of the lead product of the company?








Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)