As they are going for a registration trial the FDA will need a say into what sized cohort is needed.
But, since the trial will be into a disease with an umet need, and because PTX100 has shown such a good safety profile, they may not require a large number of arms in the trial.
The results already achieved in trials so far would be sufficient for a approval.
With only a registration trial hopefully to commence in a. couple of months, this $36million market cap is crazy!
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