Yup. The only way that you can skip the required P1 and P2 trials and go directly to a P3 trial is if you are going to repurpose a drug for another disease.
IMO, this is confirmation that Anavex will in fact be repurposing A2-73 after it is approved for Rett...which is exactly what I had outlined in my previous post a few weeks ago. (See below)
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abew4me
Post# 426544
Wednesday, August 09, 2023
Yes. I think they'll present the OLE as an alternative to a full-blown confirmatory trial because their NDA (New Drug Application) will be focused on repurposing A2-73.
This has been Anavex's plan from the beginning (IMO)...but the Covid virus delayed the approval of Rett. Now everything is back on track!
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 by simply repurposing A2-73. (Qualifying for the $100M voucher is a bonus)
Our FDA guys know what they're doing...especially Dr. Jin.
TGD and his team know what they're doing. Just sit back and enjoy the ride.
