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To: Claude Cormier who wrote (8369)1/7/2002 5:31:43 PM
From: Mark Bartlett  Respond to of 14101
 
Claude,

I am not sure about the phase II but the phase III had a few hundred. In addition H/C allowed DMX to do a phase IV that involved about 3000 patients and over 100 doctors.

MB



To: Claude Cormier who wrote (8369)1/7/2002 8:41:16 PM
From: Cal Gary  Read Replies (2) | Respond to of 14101
 
Hi Claude

This is all I have:

Phase III (2) Canada double blinded 194 2-Oct-00
Phase IV Canada unblined 3500 Dec-99

There were 2 Phase III clinicals done for Pennsaid.

The first was submitted to both FDA and HC.

HC requested a more up to date second phase III which DMX happened to have in their back pockets at the time. This second double blined Phase III enrolled 194 patients and used the WOMAC standard. News Released Oct 2, 2000.

It is believed that the FDA did not require the second Phase III. There is debate whether the second Phase III was forwarded anyways to the FDA.

Hope this helps. I'd be interested in filling in the blanks in my worksheet.

DMX: A company with 2 Phase III drug products