Rock,
That is the piece that doesn't make sense to me. If the companies trial protocol called for 350 mg and the results were stellar, as they were, why would the FDA just not approve the drug based off of the trial protocol for the dosage? Selfishly, I am glad that they did not as I would not have discovered the company if not for COVID. As a relatively new investor, I plan on staying regardless of the COVID results, as I believe the company has tremendous potential for many indications.
Is it possible that the FDA would approve mono therapy without a long drawn out trial? I think that was alluded to in a conference call at some point. If that is the case, is the delay worth the wait for approval, as this would open up additional revenue stream years earlier then what would have happened with having to do a trial. Just giving my thoughts, I could be way off base on my thought process, but that is how I am looking at it.
GLTA
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