For me, the issue that seems to have been more or less ignored in these discussions is the events of 2020, which have sent a seismic storm through the procedures for assessing and approving treatments built up over the decades following world war 2. Last year 3 or 4 or 5 new vaccines for COVID-19 were developed, tested, and approved by all the national authorities plus the W.H.O. None of this would have been considered possible until it became necessary.
While tens of thousands of trials were conducted, haven't the the approvals of these vaccines in such a brief period completely changed the rules, or necessitate a complete reworking of the rules which applied prior to last year ? Isn't that the reason why the FDA have entered into these meetings - because they recognise that the events of last year have changed things forever ? and isn't that why organisations like the PPMD are pushing to speed up the actions to produce a cure for their devastating illness.
I just don't see that the negotiations now underway will be just a matter of carrying on from 2019 on a business as usual basis
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