Only in your world does the applicant give the regulator "guidance".
LOL whytee only in the real world where the regulator has no policy because it is a NOVEL therapy.
How about keeping to the facts?
The FDA are still developing their policy on the run and now consulting.
MSB and Teva (formerly Cephalon guided the regulator because they had no clue.
And the regulator needed help in weeding out the backyard operators.
They still need help and that's why they're asking for it.
They have been inconsistent with MSB and they admit that implicitly by agreeing that ignoring the advice of their own expert bodies is not a good look and implicitly undermines the credibility of the organisation as a regulator.
Cell Therapy News/Articles, page-17113
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