Is the reasoning behind the expectation of getting a BTD this round because of the platform potential of NNZ-2591?
I dont know the particulars of why trofinetide was knocked back for a BTD except that the data at the time was deemed insufficient to receive the designation. This time might be different because you now have 3 Phase 2 trials showing a signal of efficacy in a range of disorders where the subjectivity in measuring outcomes decreases.
Perhaps if it's knocked back this time, there may be a chance for HIE especially if the FDA agrees to a pivotal Phase2b/3 trial. But I wonder about the preclinical evidence and whether its enough to support the request for a BTD, perhaps given the devastating nature of HIE coupled with results from the 3 trials this could push the FDA to act in the affirmative.
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