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Biotech / Medical : Arena Pharmaceuticals (ARNA) -- Ignore unavailable to you. Want to Upgrade?


To: scaram(o)uche who wrote (1639)3/16/2010 7:31:03 PM
From: targetedmoab1 Recommendation  Read Replies (1) | Respond to of 2274
 
Rick
Honestly it is going to depend on many factors for the length of each trial.
Some factors are:
- Length of IRB and Scientific committee review or is there a central IRB which cuts time.
- Do they have patients screened to get ready for trial?
- Contracting and attorney review then site initiation visit
- How interested are the investigators in the trial? Excited enough to promote within the institution or surrounding referral base to increase patients. How many patients do they see and are there any competing protocols?
- Will there be any revisions in the protocol during the trial?
- The evaluation of the SAE's after each dose before stating the next cohort.

There are actually many other parameters such that you can't say there is an average.

I've seen Phase I completed in as early as 6 months and as long as 2 years or more. As far as 1 B? Again, is there excitement around what they see from previous co-horts that they will put every patient that qualifies on the trial?
I've seen fast accural and I've see it slow enough that you have to open more sites.
It's not as simple as saying IND approved, then start Phase I right away, then II, then III, then approval. Approval of a drug is long and expensive