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12:18
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Originally posted by otherperspective:
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This is not about my ranting as a disappointed shareholder. This is about the actions of the FDA, who have contempt for their own process and choose for the first time in 16 years ? to go against their own expert committee (ODAC) who recommended approval of this therapy. They will have blood on their hands. Any mother who has a child suffering with Grade D acute steroid refractory GVHD will now have little chance of saving them from an agonising and certain death ....because some egomaniacs choose to make an example out of Mesoblast not using a double blinded randomised clinical trial. Never mind that the a single arm study was used to approve Jakafi in adult srGVHD or Imbruvica in Chronic GVHD, these heartless individuals want to make a point... Ryoncil had a fantastic safety profile, compared to the latter therapies . The FDA is inconsistent in its applications of its own laws and I think shows bias and incompetence in its own briefing documents , in relations to comments made about null hypothesis, single arm studies and number of passages affecting senescence (which are irrelevant to our process as we only go up to five not the seven they referenced , etc. They are a disgrace. Heads should roll. Since when as the regulator, do you ask your applicant to come up with a revised set of rules? (potency assays and bio markers) after THEY have presided over a match in which they set the rules...agreeing a trial design with similar endpoints to all the other trials for successfully approved therapies. Temcell in Japan and Alofisel in Europe use the same/similar technology and have been approved ...the FDA is totally out of order . I look forward to their explanations , WHEN in my opinion, this therapy results in overwhelming efficacy in our Covid 19/ ARDS trial at either the 45% or 60% interim analysis they will be exposed for the fools that they are. In my view they are an utterly incompetent , not fit for purpose organisation.
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Agreed @otherperspective - this is so disappointing!
(20min delay)