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Posted On: 07/30/2020 6:29:43 PM
Post# of 153903
Quote:Although I am happy to be corrected, my understanding is that FDA approvals are typically granted on the basis of a second Phase 3 Trial which can be called either Pivotal or Registration.
The current Single Agent trial is labelled as 2b/3. So what is the difference between 2b/3 and 3? More Patients? Different End Pt?
Dr.NP has declared on several occasions that the Mono indication would not be approved as a Label Expansion -- and that it would require a Registration Trial.
In Dr.NP's verbal list of the 10 trials he hoped to have initiated by the end of the year, the Mono trial was the only Phase 3 (see my just posted Catalyst List).
I don't know if the FDA would ever budge and allow the Mono to be somehow fast-tracked such that the Phase 3 Registration could be avoided -- but it would be an absolutely amazing outcome with very material revenue consequences.
However, I don't really expect this to happen. It's better for me to be pleasantly surprised -- than disappointed.
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