Tuesday, December 03, 2024 7:28:02 AM
Can't definitely say there wouldn't be any other kind of trial but if there ever was hopefully it would be post approval.
The idea that the EMA would not at the very least give conditional approval (the benefits are greater than the risks) would be kind of absurd when they have approved Lecanumab which even in the sub-group approved had a weaker ADAS COG & CDR SB score vs placebo than Blarcamesine and worse risks in terms of safety (outside of the small risk of death from drug Lecanumab has been approved despite it not being clear yet why it seems to shrink the brain).
To say otherwise I would suggest someone has some kind of financial incentive in it taking a lot longer for patients to try Blarcamesine rather than having patients interests at heart.
The variant finding was very low p value - 0.0001 but doesn't necessarily mean much yet due to the sheer number of genes and variants looked at as it could be argued they may have been bound to stumble on one with that level of significance (sigma wt sub-group which showed improvement was obv pre-specified though). However the OLE looking positive (from title) is great news and clearly was seen as significant enough for Dr Sabbagh to do a 15 minutes presentation on it at the AP/PD summit.
The idea that the EMA would not at the very least give conditional approval (the benefits are greater than the risks) would be kind of absurd when they have approved Lecanumab which even in the sub-group approved had a weaker ADAS COG & CDR SB score vs placebo than Blarcamesine and worse risks in terms of safety (outside of the small risk of death from drug Lecanumab has been approved despite it not being clear yet why it seems to shrink the brain).
To say otherwise I would suggest someone has some kind of financial incentive in it taking a lot longer for patients to try Blarcamesine rather than having patients interests at heart.
The variant finding was very low p value - 0.0001 but doesn't necessarily mean much yet due to the sheer number of genes and variants looked at as it could be argued they may have been bound to stumble on one with that level of significance (sigma wt sub-group which showed improvement was obv pre-specified though). However the OLE looking positive (from title) is great news and clearly was seen as significant enough for Dr Sabbagh to do a 15 minutes presentation on it at the AP/PD summit.
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