Daniel, can you comment on what are the remaining steps in the process of turning this cGMP-quality dihydrochloride into RC220?
presumably Ardena do their thing of formulating the RC220 composition, but then what happens?
do pharmacokinetic and other studies happen in animals and humans to make sure RC220 doesn’t precipitate and that it seeps into the body just the way it is supposed to?
does the FDA have to give its approval of RC220 an an acceptable new drug suitable for clinical trials in humans?
anything else?
has an approximate time estimate been given for when all these steps will be completed and RC220 is clinic ready?
I tried to ask these questions in the investor hub but it didn’t seem to be working!
Ann: Bisantrene cGMP API Manufacturing Completed at Laurus Labs, page-19
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