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boi568

09/30/25 9:24 AM

#501736 RE: Doc328 #501731

Re: 5 percent and the need for another Phase 3

I have examined all of the MAA disapproval recommendations over the past twelve months and found several small, single trial examples. None of those disapprovals, however, cited the lack of a second trial in explaining the reasons for the negative opinion. I don't know where you are getting this requirement from.
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LakeshoreLeo1953

09/30/25 9:53 AM

#501740 RE: Doc328 #501731

That IS the correct syntax evaluation of the claim.
I gather even "Baked" has accepted that distinction.
However, less formal interpretation AND movable goal posts
for eventual unrestricted label approval make for great FOMO.
Opening salvo today may be indicative of exactly that.
If the $9 resistance becomes aggressively attacked I'll participate
if only on that FOMO. the $ .25 from present levels will be insignificant
and I do hate falling knives.

Anavex has presented a case to CHMP that is worthy of consideration.
Approval of ANY kind would be a significant success.
Limitations on that approval may very well delay the moonshot
of the SP predicted by many true believers.

IF in fact all the "new News" is indeed credible it may serve as mitigating
any real world disappointment in the wording of the EMA statement before or after the New Year.
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jtsmgoblue

09/30/25 10:03 AM

#501743 RE: Doc328 #501731

Do you play a Dr on TV too?

Get to work
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abew4me

09/30/25 10:29 AM

#501750 RE: Doc328 #501731

Doc. If Novo Nordisk reports a failure of their AD study, the EMA will not have any AD drug therapy...other than the Mabs - which are not practical.

IMO, the Novo Nordisk's failure will be a HUGE incentive for CHMP/EMA to approve Anavex's 2-73 drug.