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Message: ABL- COVID-19 Therapeutic

"Don't know how long this would take post a successful clinical trial."

Trials, not trial. It would need to start probably Phase 2, if not Phase 1, for COVID-19 population. Potential approval would come post-Phase 3 completion, or during Phase 3 after interim Phase 3 analysis (i.e. Emergency Use Authorization). 

"We know safety is not a concern having 9 DSMB safety designations by way of BOM."

Apabetalone would first need to be proven safe in COVID-19 population. This has never been tested. The 9 DSMBs from BETonMACE do not give apabetalone a free pass for safety in a new population/condition.

"And if ABL is FDA approved for COVID-19 would this mean ABL can be prescribed off label for other medical conditions. This may be the fastest way to get ABL to market."

Possibly. Though Resverlogix would not be able to claim any cardiovascular, renal, or other benefit other than those proven in COVID-19 trial for treating COVID-19. Additionally, if we are just talking about Emergency Use Authorization and not full FDA approval, then apabetalone would likely be very restricted in is application of use. Lastly, without proven clinical trials for other conditions, it is likely that very few doctors would use apabetalone for other off label conditions. Some, but likely not many.

BDAZ

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