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FeMike

05/14/24 10:47 AM

#691433 RE: flipper44 #691429

Your beloved AI machine said that Phase II is the phase in which they focus on " the evaluation of the safety, efficacy, and quality of the medicine". It does not mention these things being reviewed in Phase 1, which focuses on "the administrative and procedural aspects of the application, such as reviewing application forms, data on the medicine's quality, non-clinical data, and details of the proposed labeling and packaging"

Are you trying to tell me that if the forms are correct, the non-clinical data looks good, and the labeling and packaging is sufficient, they will simply approve the treatment giving no consideration to the "safety, efficacy, and quality of the medicine" which occurs in Phase II?

Huh...that's interesting. But I suppose you're right again.

manibiotech

05/14/24 10:53 AM

#691435 RE: flipper44 #691429

So going to Sept or Oct , how would have they well spent those 10M pounds to revolutionize approval process and expedite it . This by the way is accelerated approval