Biotech Values

[DewDiligence]

Re: GENR SPA

The SPA does not mention the number of patients because the number is supposedly dependent on how well Evizon performs in the phase-2 “209” study. I.e., the better Evizon performs relative to placebo in the “209” study, the fewer patients will be needed in the phase-3 trials to reach a given level of statistical significance.

That’s the theory, anyhow. This is the first time I’ve seen an SPA with a variable number of patients.

How many patients are likely to be needed in phase-3? Here’s what I posted about this in January (#msg-5183359):

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In phase 3, Macugen was tested on approximately 900 patients for two years. For Squalamine, I think the FDA will ask for 1,200 patients for two years (probably in dual trials with 600 Squalamine patients each).

If the above is correct, counting control arms the total number of patients to be enrolled is 1,500-1,800 depending on whether the randomization is 4:1, 3:1, or 2:1.
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