posted on
Apr 24, 2022 01:58PM
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Message: Re: BTD
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tada - I'm not disagreeing with you rather pointing out how the FDA might see this. They have given a way for Apabetalone to be moved along and get a possibly fantastic drug to those that need it yet they see the program just sitting there. It is up to management to get a partner or financing however they have to and move this forward. They don't and the BoD allows this to continue without getting someone that can get it done.
"The idea was to do a COVID trial with APB at a small cost, comparatively, have a significant share price increase and then do the BoM2 trial without significant dilution for existing shareholders."
The above is not a company stated plan rather your along with many others (and maybe even mine) supposition of their plan. It might be true and might not. My question was how does the FDA look at the lack of action after they tried to speed getting this to patients if it works. The BTD awarded was not for a COVID treatment, it was " Breakthrough Therapy Designation for apabetalone in combination with top standard of care, including high-intensity statins, for the secondary prevention of major adverse cardiac events in patients with type 2 diabetes mellitus and recent acute coronary syndrome."
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