News Focus
News Focus
icon url

Simonizer

09/21/22 10:45 AM

#374422 RE: Bourbon_on_my_cornflakes #374420

9.63 +.43 HOD
icon url

raja48185

09/21/22 11:50 AM

#374431 RE: Bourbon_on_my_cornflakes #374420

One obstacle. Glacial management's inability to get a p3 trial even STARTED after more than one year. WhereTF is it already?

Seems to me that you did not get the memo . Come on man!

Anavex (with those 2 ex-FDA guys) is helping the FDA set up a separate AVXL division in the FDA organization. Given that there are so many catalysts for 2022, everything will be going full-speed starting October 1, 2022.

The new division will cater to reviewing submission from AVXL in the next 4 to 8 weeks - ranging from : PD, PDD, AD, Rett (all 3 trials - separate and combined - all combos ), MS,Pain, and new trials for all the indications mentioned in the pipeline, including that 'no-name-till-now' disease.

The final week of the year is reserved for granting approvals.

So no Thanksgiving/Christmas/New Year holidays for those FDA guys, including those at Anavex, as they work hard towards getting approvals for all the diseases.

Nothing to look forward to in 2023, as everything gets done in 2022.