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fabius

09/19/16 5:04 AM

#17753 RE: AngeloFoca #17749

Angelo, Samsa,

I'm as technically prepared as both of you (even if in different grounds),

but I think that your two different reasonings about PODRAS could come to a solution (forgive if I'm wrong on this one):

from the company press release:
"About Rexista™ Oxycodone XR incorporating PODRAS™
The Company's Rexista™ Oxycodone XR product candidate has been further enhanced with its proprietary PODRAS™ delivery technology intended to reduce the likelihood of oral abuse when more pills than prescribed are swallowed intact. Preclinical studies of Rexista™ Oxycodone XR suggest that if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected."

Angelo I tend to believe that preclinical studies have already been conducted; if you look at the wording in bold they are clearly referring to the PODRAS technology.

If that's true I would stick with Samsa reasoning about the supplemental NDA, which explains the delay in Rexista filing as linked to PODRAS patent, most likely than not included in the Agreement.

Comments more than welcome