I think the patient size for p2 is a double-edged sword. If you have too few, you can’t get reasonable comfort of replicating that in p3 while if you have to do a reasonably big p2 then it is quite costly for the company. So I like the tack that some companies like ATX have taken by using a Bayesian trial design- they had 26 in the first cohort of phase 2a, and based on the safety and efficacy recruited 24 more into the same phase 2a trial. This is too for a rare form cancer is reasonably large for phase 2.
In short, it is subjective and has to be approved by regulators to be representative of the final patient population. The companies have to agree to this design requirements but also appropriately fund it as the trials can take a few months/ years to complete and the results can usually be binary both for the trial and the survival of a small biotech.
Fingers crossed for positive results in our therapeutic arm and hope to have the phase 3 commenced or completed this year.
No advice. I am just a lay investor.
ILA Price at posting:
15.5¢ Sentiment: Hold Disclosure: Held
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