Saturday, October 24, 2020 4:35:02 PM
I could be mistaken, but I believe that at least some of the discussion of the RMAT came from a remark LG made about discussions with the FDA in his recent broadcast interviews. The assumption was, if they're speaking with the FDA, what other reason could they have.
I never heard of RMAT before I heard about it here, but after seeing what it was all about, it makes sense that they'd try for it. If they don't get it, I expect that nothing will be said about ever trying.
I believe many discussions with the FDA are never revealed, even when you get what you want. The SAP is a perfect example, I believe after possibly several submissions and modifications it was accepted, nothing was announced as the FDA frowns on what they'd consider as hype regarding what they've agreed to. The acceptance of the RMAT ought to be able to be announced when it's been formally agreed to.
Gary
I never heard of RMAT before I heard about it here, but after seeing what it was all about, it makes sense that they'd try for it. If they don't get it, I expect that nothing will be said about ever trying.
I believe many discussions with the FDA are never revealed, even when you get what you want. The SAP is a perfect example, I believe after possibly several submissions and modifications it was accepted, nothing was announced as the FDA frowns on what they'd consider as hype regarding what they've agreed to. The acceptance of the RMAT ought to be able to be announced when it's been formally agreed to.
Gary
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