Sunday, November 06, 2022 10:20:03 PM
HyGro,
An approval in the UK does not require that much time (months to prepare then 2 months plus 10 months) when an MIA is already submitted. A statement like “will take months to prepare” writes off likely rolling type submissions to both FDA and also MHRA, which is waiting on commercial scale manufacturing certification, and ignores circumstances whereby FDA and MHRA can keep things under wraps so that otherwise publicly known dates are kept quiet. Start researching all the exceptions and it doesn’t take long to figure out that false claims while multitudinous are sorely lacking the clarity available in the regulator guidance. Sadly, this reminds me of what was written in Deep Capture about repeating the same things over and over to create a desired effect. Best wishes.
An approval in the UK does not require that much time (months to prepare then 2 months plus 10 months) when an MIA is already submitted. A statement like “will take months to prepare” writes off likely rolling type submissions to both FDA and also MHRA, which is waiting on commercial scale manufacturing certification, and ignores circumstances whereby FDA and MHRA can keep things under wraps so that otherwise publicly known dates are kept quiet. Start researching all the exceptions and it doesn’t take long to figure out that false claims while multitudinous are sorely lacking the clarity available in the regulator guidance. Sadly, this reminds me of what was written in Deep Capture about repeating the same things over and over to create a desired effect. Best wishes.
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