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Re: rkrw post# 98686

Monday, 07/12/2010 11:01:32 PM

Monday, July 12, 2010 11:01:32 PM

Post# of 252497
I agree here. The value enhancing events would be:

1. Agreement with the FDA on the pivotal trial design.
2. Full enrollment (marginal as everyone knows this trial will enroll very quickly).
3. Results from trial
4. NDA
5. Approval

In this particular case, 2-5 will provide less added value than is typical for most drugs, because any partner understands that the drug has very low clinical/regulatory risk even at this very early stage.

That means that immediately after step 1. is the logical time to partner. So absent any sub-optimal behavior from Harvey, that's the timing I would predict, which fits in with your prediction too.

Peter

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