Cap., "Sad?" I would call it what it is, "corrupt!"
Corrupt?
The FDA made an early approval decision on the Keytruda sBLA is all. They are getting almost cookies cutter now. Merck knows exactly what the FDA wants to see. And no need to review CMC, other trials and pre-clinical. There is no reason at all for approvals like this to need as long a review as a totally new BLA.
That the early decision might have hurt AGEN is sad. But the FDA is not supposed to withhold approvals because it hurts another company's prospects.
BTW, the CEO of AGEN was tossing BS in the public PR when he was talking about the MRK using 1st line data to get the second line conditional approval converted to a full approval. That is very normal as it is hard to run a trial once already approved in an indication, so confirmatory trials are often in related settings. And th3 Keynote-846 has been known for years to be the confirmatory trial for second line.
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