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Biotech / Medical : Welcome to the POTP board, the DPP-IV company
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To: rkrw who wrote (77)5/15/2007 11:03:39 AM
From: pgo-neil  Read Replies (2) of 90
 
Hi Jim,

Thanks for the PR notice...

Obviously they are scrambling for some positive news to allow them to raise capital quickly. I think even in a life boat drill, they only have about 4 to 7 months cash in the till. A couple of points that might be relevant:

1. Timing... if they complete this month, they should be able to get the results in a late breaking poster for ASCO. As late as March, they were projecting a complete enrollment [N=400] in the second quarter. To find in the middle of May that they are still 40 away shows a slowing of enrollment.

2. The Ph2 Pancreatic is still being followed and they announced in March that they expected to complete the trial in the second quarter and report. Even though they were going to miss 6 month survival, they did have 5 Responses out of 51 evaluable. Another 19 patients could move into evaluable for the completed follow-up. Maybe they will have some other ASCO news... Or maybe it will be too late... or maybe not very good news either.

A question [with relevance to DNDN]... I would think this unscheduled peek would have to be coordinated and approved by the FDA [the stat analysis as a minimum]. But I don't find any reference to that sort of coordination in the PR. How standard is this approach [with or without FDA approval]?
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