Well for one thing, trials will still need to be d
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Posted On: 10/06/2020 2:42:20 PM
Well for one thing, trials will still need to be done in the US. The FDA is not going to accept Malaysian trials as the final say. They will most likely be able to use that data as part of the approval, but FDA will want 20K+ participants done under US FDA trials.
I agree Bintai is to pay for the trial costs in Malaysia, and elsewhere since I believe they mentioned trial sites worldwide, but we need the FDA IND approval and not "yes, looks ok" in the comment letters.
I agree Bintai is to pay for the trial costs in Malaysia, and elsewhere since I believe they mentioned trial sites worldwide, but we need the FDA IND approval and not "yes, looks ok" in the comment letters.
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Disclaimer: Of course, all of this is my opinion and you should not make any investment decisions based on my opinion. I have not received any non-public information.
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