InvestorsHub Logo

Steady_T

02/11/24 2:24 AM

#451631 RE: crescentmotor #451628

You are willing to put a stake thru the heart of Rett at this time. I suggest that is a mistake. The status of Rett is not known until the FDA renders an opinion.
If the FDA says go ahead and file an NDA then things are back on track. If the FDA says run another trial then AD should be full on.

Even so, Anavex has the resources to run multiple trials at the same time.

At this point AD is at the NDA preparation process stage, not running trials stage so the cost is manageable. Running the 3-71 trial along with an additional Rett trial would not be a huge cost. Fragile X trial will not be a long trial and will likely not require a very large number of subjects so its costs will also be manageable.

Two things will determine Missling's ability to raise money at a reasonable cost. The FDA Rett decision and the contents of the AD peer review paper.

Until those items are known Anavex and the SP is in a holding pattern IMHO.

Investor2014

02/11/24 2:30 AM

#451632 RE: crescentmotor #451628

Regarding Rett. I would like to hear about deeper analysis correlating the, although not standard accepted, biomarkers GABA/Glutamate, seizure frequency and severity, S1R expression and perhaps more correlated to drug vs. placebo. In addition the analysis that Kaufman proposed and Missling stating in the Q1 cc the company's now better understanding of the large placebo response, all held together and the response to that from regulators.