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growingpain

12/02/22 6:30 AM

#387523 RE: Hoskuld #387521

Yeah, I think a CC would be great today, it will also give some further publicity, no significant coverage from the media yet
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Tom_Green

12/02/22 6:47 AM

#387539 RE: Hoskuld #387521

Yeah that's what they should have done from the beginning in stead of trying to rush the data for the CTAD conference. Maybe it was a way to pressure the CRO to work through the data faster but it bit them badly this time. They could have presented the data at a conference after the topline was released with nice scientific fanfare for the academicians but the initial release should have been crisp and clear. The management got their priorities mixed up. Not good.

I hope the patient group who titrated up to 50mg and stayed there has a sufficiently high effect to reach stat sig on its own. In the P2a the low dose had such a moderate effect that if the effect stands also in this trial then combining them together should really pull down the magnitude of the effectiveness of the high dose group.

BTW, I have been long this stock since 2015 and this marathon is not over yet. Maybe past the half way mark though.
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dmb2

12/02/22 6:52 AM

#387541 RE: Hoskuld #387521

Circumstances dictate top line critical stats should be correct while underlying supporting stats which are shared may be fine tuned, though any stats with serious questions should be withheld and not divulged initially but reserved for confirmation. Startups tend to show their lack of horsepower when they stretch too far and stumble but it does not change the directional facts.

My opinion only but I am not sure AVXL did not have agreement from RA's to conduct this trial and publish its results as a titratable drug assuming safety has been studied at both ends of the range and guidelines for titration have been established prior to the trial. As we all know there are many drugs that are administered to patients in practice on a titratable basis such as cholesterol drugs as one example. There has been much work on adaptable trials to make them more conducive to product development and approval decision making. Maybe this type of patient dosage management is what AVXL sought to establish and had agreement to study it that way given their prior safety and efficacy studies.

I have followed AVXL from a distance for a long time, GLTA!