feeling a bit disoriented by FDA’s lack of transparency, clarity or helpfulness. It’s a rare occasion when two parties can’t agree on simple math. We can’t work with shambolic regulations. This is not how you win support for innovation.”
Gee, yeah, we all have such confidence in the FDA, you know, the FDa that approved Aduhelm. They're just peachy.
I agree the SAVA CEO is a promoter, but his opinion about the bureaucrapts at the FDA sounds legit to me.
Dr. M seems focused on TGA approval, wonder why if the FDA is so clean and spotless.
Anavex CEO Missling has NEVER been rejected by the FDA.
Can't be rejected if you never put a drug up for approval.
I think Dr. M is smart enough to know the FDA will give him similar "you're not BP, you're a crappy little biotech" treatment. Hence the Rett strategy, and PDD, and the TGA, all likely before trying to run the FDA gauntlet on alz as a small biotech.
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