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HMB2010

12/08/21 9:30 AM

#339154 RE: sokol #339153

Forefront and as precision medicine needs to be for all rx going forward. The "one size fits all" even in otc meds is erroneous.

"patients that vary in age, size, condition, genetic make up, etc."

plexrec

12/08/21 9:33 AM

#339156 RE: sokol #339153

" I am confident that AVXL 2-73 will get there,"--thanks sokol-- well said--I am in the same camp (been invested here over 6 years)--not selling any shares--believing "our day will come"-just taking a bit longer than I had hoped but still confident our payday will be big !!!! GLTU !

Ortiz

12/08/21 9:51 AM

#339159 RE: sokol #339153

“Labeling is also a hurdle in the approval process. Anavex will have a lot of work to do to get the labeling approved for each indication that AVXL 2-73 may treat in patients that vary in age, size, condition, genetic make up, etc.”

Thanks for bringing labeling to the conversation as labeling, or the package insert (PI), is not as easy as many would think. The material presented to the FDA must be detailed and consistent with the trials results, otherwise Anavex will be required to make corrections, which contributes to delays.

Hopefully Anavex is using its time wisely to hammer out the PK/PD of 2-73 section and create a general template where pertinent information would be inserted once the data is analyzed.

IMO

IMO

Boopka

12/08/21 9:59 AM

#339161 RE: sokol #339153

Sokol, excellent comments and greatly appreciated. Just wondering, you indicate that it will take time for Anavex to get it right. Do you think Anavex is at any disadvantage versus other competitors when it comes to time to market? I am of the belief, probably like many here, that Anavex has the goods. I am wary, however, of us getting outflanked and losing first to market status or simply being delayed too long by the complexity of our MOA and its uniqueness. What is your take and thanks again!

powerwalker

12/08/21 10:50 AM

#339188 RE: sokol #339153

Kudos, sokol, for your recent posts. Mercí Beaucoup.



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