Well said. CTAD will open the curtains a bit wider, but there's still much to be done to prove out the drug. The Alz Ph3 trial start will be the next important catalyst, followed by a Retts top-line that shows stat-sig efficacy.
“seamless trials” emphasized by both Drs Gottlieb and Woodcock of FDA in recent speeches to RAPS should help. I saw a report that JW said that the current FDA system of clinical trials is “broken”....too costly in time and money. RWE may well be in the future.
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