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Prurisol schedule.

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a1derfullife   Sunday, 03/03/13 03:55:10 PM
Re: None
Post # of 341485 
Prurisol schedule.

Looks like the Prurisol POC trial in Europe will be later than originally expected. From the company PR on February 25th:

Dr. Reddy’s has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013.

My understanding is that, as part of the formulation stage, Dr. Reddy's must verify that the drug is stable for a 60 day period, ie, once they've produced a batch using the final manufacturing process, they must test it, store it for 60 days, and re-test it, to verify it has remained stable over that time.

If they finish the first batch using the final manufacturing process by the end of March, the schedule might look like:

Initial test: 1 week (finish on April 7th)
Store for 60 days: 60 days (End on June 1st)
Final test: 1 week (finish on June 8th)

This implies that the POC would start around the end of June, assuming all goes well.
Assuming all patients in the trial begin the trial by July 15th, and the trial takes 60 days (30 days of dosing, followed by a follow-up 30 days after the end of dosing), puts the end of the trial at Sept. 15th. Assuming 15 days to analyze the data and put out a press release puts the date for a PR on the Prurisol POC trial around Oct. 1 - significantly later than I'd been expecting.

A1

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