banter and General Discussion, page-7010

.... you tell us exactly the same thing every day ad nauseum - we get it; you're not a fan .... and as for this comment below - laughable ....


I worry that the other trial failures, which had not occurred by the time of the initial BLA issues, won't weigh on the FDAs mind regarding the efficacy of these cells.


..... and let's not forget the FDA were happy to authorise Remdesivir to treat COVID-19 even though it did not meet efficacy endpoints previously to treat Ebola ... sort of substantiates the fact that the FDA assess BLA's / NDA's on the specifics of that particular indication doesn't it so claiming that the FDA will look at totally different treatments for irrelevant indications just because they are associated with the same company is a stretch to say the least ?



As for your claims of trial failures - Oh you mean these stellar CHF results that the FDA are particularly interested in meeting about and have requested specific information on previously on multiple occasions .... and again Remestemcel-L and Rexlemestrocel-L are very different treatments for very different indications but do bang on with your FUD if it makes you feel better .... enough said