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boi568

09/21/25 3:48 PM

#501243 RE: La Flaca #501239

It's not 100 percent certain we are in the second clock stop, but it is extremely likely that we are. I don't buy the oral argument suggestion; oral arguments before CHMP are unusual (and signal there's a major objection being discussed).

Even if we are in clock stop 2, it's theoretically possible for the issue to be resolved quickly enough for the October meeting, but that's also very unlikely. I think it would take a very minor issue for things to happen that fast.

While this could drag on until December, Anavex should be incentivized to respond to an LoOI before 30 days are up so that any approval recommendation can occur before CTAD at the beginning of December. I expect our wait will be over on Friday, November 14th.