Tuesday, April 28, 2026 7:16:26 PM
Agreed, and that is exactly why I shared it.If you go back and read my initial three questions, I did NOT use the term conditional approval.Instead, I asked whether any manufacturing preparations were underway in anticipation of full approval.In other words, it may be as simple as him not knowing the precise status and responding to my question as best he could.At the same time, there could also be something more to it.As Baxers astutely pointed out, one of the primary reasons some MAAs can take well over two years to reach a decision is when regulators are considering a form of conditional approval or requiring additional commitments before granting full authorization.Of course, conditional approval can cover a wide range of scenarios.At one end, it could involve significant requirements such as confirmatory Phase 3 or post-marketing trials to further establish efficacy or safety.At the other end, it could be more limited conditions, such as enhanced pharmacovigilance, patient registry participation, manufacturing validation updates, labeling refinements, or additional patient monitoring protocols.My only point is that his response should not automatically be interpreted one way or the other.It may simply reflect incomplete knowledge, but it could also hint that there are ongoing regulatory or manufacturing steps still being worked through behind the scenes.
Bullish
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