Replies to post #239034 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

https://www.sciencedirect.com/science/article/pii/S235287371830026X

There is a long FDA performance-science success/fail history. As we have noted here, there is nothing to suggest the FDA has managed this process effectively. Note 99.6 % failure 30+ years and billions spent while many, many patients have passed.

Eventually, it is all about the science, regrettably the BIIB PR process has been historically deployed when they should have just kept their mouth shut.

[Doc328]

1. Biogen’s so called FDA arm twisting might not be working as they hoped (so, either they might nit be able to re-run them or approval is proving to be harder)

Biogen seems confident. I expect submission of the NDA by mid April. The AD national sales management team has been hired. Most regional sales directors have been hired and they are scheduling interviews for area reps. I've heard they will have a distinct sales force from the MS reps.

I feel the odds Aducanumab gets approved are > 50:50 though no slam dunk. Drug companies have hired sales forces only to lay them off after a rejection in the past. As Biogen said late last year, the trial sites are being re-initiated with plans. If approved, I expect they will need to do a good sized phase IV.

Anavex shareholders should embrace this possibility. Just the knowledge that a drug can succeed with MS will elevate the SP. If Anavex is better than Aduca, and it appears safer, then A273 will do great and the annual drug price might be set higher than it would have been set because of aducanumab(cost of aducanumab is drug price plus several thousand a year for infusion plus probable need to check MRI around 6-8 weeks and maybe a second one). If Anavex is not as good as Aducanumab but good enough to be approved, combination therapy will still be looked at and it will be used in those who may not be infusion candidates.