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Re: bas2020 post# 425566

Wednesday, 08/02/2023 11:31:57 PM

Wednesday, August 02, 2023 11:31:57 PM

Post# of 462058
Once A2-73 is approved for Rett, Anavex can repurpose the drug for Alzheimer's Disease...which will expedite the approval process. (See explanation below)

Drug repurposing, or repositioning, is a strategy aimed at identifying new uses for already approved drugs, which fall outside their original medical indication. This strategy has led not only to the successful preclinical and clinical testing in multiple neurological disorders, but also to the reevaluation of disused drugs, epitomized by the remarkable case of thalidomide.

In recent years drug repurposing has covered a wide range of neurological disorders, from neurodegenerative and neuropsychiatric to drug abuse-related disorders.

Alzheimer’s disease and Parkinson's disease, for example, are the two most common neurodegenerative diseases, for which only symptomatic therapies are available, while neuroprotective drugs are still an urgent unmet need. They are therefore in the top list of neurological disorders for the investigation of repurposed drugs, targeting both the disease neuropathology and symptoms.


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The FDA can approve an NDA (New Drug Application) with one successful P3 trial and the repurposing of an FDA-approved drug.

So, if the FDA approves A2-73 for Rett, that would qualify for the first half of our Alzheimer's application. The other half would be our P2b/3 AD trial.

IMO, this is the main reason why Anavex wants the FDA to approve Rett first. Once it is approved, they can expedite the entire process for our Alzheimer's application. (Qualifying for the $100M voucher is a bonus)

Our FDA guys know what they're doing...especially Dr. Jin.

I'm just sitting back and enjoying the ride. smile

Cheers.
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