Interesting approach.
Worst reason I could think of - since data could not have been evaluated and we have no notice of severe adverse effects - would be the FDA colluding with BP to delay development. I don't think that makes much sense, given that the new ask of 10 additional patients, with relaxed standards, appears to be pretty light. That would be a very ineffective way of achieving this assumed intent.
My assumption is that, as we know, the company applied for ODD and was denied because the patient population was deemed to be too broad. Then the company says "well hey, the patient population you're restricting us to for the combo phase III is TINY - if we don't get ODD based on population size, then we want consideration for broader labeling". And then the FDA needed additional patients - with relaxed standards - to justify that consideration.
This would have been a clear failure of communication between the company and the FDA (responsibility on the company...) in the original negotiation of protocol. Another example of sins of the past that Tony is now fixing. Since Nader is still on board, you don't want to publicly throw him under the bus when the outcome is (hopefully) a short delay and consideration for broader labeling.
All pure speculation of course, but to me, it fits fact and incentive patterns pretty well.
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