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Friday, July 22, 2016 12:06:52 PM
That's part of the problem. There is much speculating. Much of it the result of the company not providing enough information. It shouldn't be a tough question.
This is why I question it. The IPCI product page for Rexista talks only about a 40mg version in the clinical trials.
http://www.intellipharmaceutics.com/product-detail.cfm?productID=118886
If you do some googling you'll find some of those trials and the 40mg info.
However if you look at a Dawson James investor presentation from late 2015:
http://files.shareholder.com/downloads/ABEA-43EQSZ/0x0x854736/66C17CE1-C63F-4D01-A71D-D5D6A0ECFCD6/IPCI_Dawson_Presentation_Oct15_2015_upload_file.pdf
And the most recent PR,
https://globenewswire.com/news-release/2016/07/05/853614/0/en/Intellipharmaceutics-Reports-Update-on-Rexista-XR-FDA-Grants-Waiver-of-NDA-Filing-Fee-and-Topline-Pharmacokinetics-Results-Indicate-No-Food-Effect.html
Pharmacokinetics Results Show No Food Effect
Following an FDA request that we assess the food effect of the final to be marketed (upon FDA approval) product of RexistaTM XR, Intellipharmaceutics recently conducted and analyzed the results of a food effect study for RexistaTM XR. The study design was a randomized, one-treatment two periods, two sequences, crossover, open label, laboratory-blind bioavailability study for RexistaTM XR following a single 80 mg oral dose to healthy adults under fasting and fed conditions.
80mgs is mentioned in each of the above. Dawson James presentation clearly indicates number of tablets and dose.
Bottomline, there are multiple XR dosage options available. This type questioning all comes from the company not being clear on such things. Investors need to understand what IPCI will be filing the NDA for. It is possible that other dosages could be submitted based on reliance of prior data.
Amigo Mike
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