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Phantom Lord

12/03/20 5:13 PM

#30631 RE: microcapbiotech #30630

I wouldn't really call the reagent issue a fiasco and it is 100% not on Peter or Marker as they are now. If the blame is on anyone it is on Marker as an entity before the merger but even that is a stretch.

The company submitted the IND. The FDA came back wanting additional information and technical specification of the reagents being used in manufacturing. The original company for whatever reason could not, or would not, provide the information so Marker looked elsewhere for a solution which I would say they found fairly quick all things considered. They submitted the new information from the new supplier which satisfied the FDA and the initial hold was lifted in lieu of a partial hold to verify the safety profile with the added reagent which is currently ongoing. It's all fair although I think the FDA was a bit nit picky with needing all the extra info on the reagent in the first place given it is not even present in the final product.

There is nothing Peter or anyone could have done other than picked a different reagent supplier when the trials were started many years ago well before Peter or most of the current management came along.

It's frustrating watching the prolonged slide but I think a lot of people are grasping at straws when searching for reasons to place blame.