Regulators could dismiss the ECA all together and just weight the evidence based on a single arm trial result. The problem, as I see it, is the extreme criteria selection meant for PFS and somewhat nebulous crossover. We'll see. But then there's the reimbursement issue. For whatever reason LP seems to be dragging her heels on it??
>>Exactly. According to the shorts, no biotech can ever conduct a medical trial based on ECA comparison because no biotech will be able to get individual patient data. The reality is that this deep level of individual patient ECA data is NOT what the FDA requires for a biotech to possess to be able to conduct an ECA comparison medical trial.
The FDA says they want to see patient level data (not summary data) for ECAs. The JAMA paper notes lack of this as a limitation. LL bemoanes the fact that this lack of data creates an issue.
Yet you and Senti think the FDA is wrong because nobody could run an ECA based trial under these conditions.
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