#57 says final design pending FDA Type C feedback, while #47 footnote 1. states the trial is being initiated prior to the type C meeting.
Although it may not actually be a conflict as the trial could be initiated but not started, as happened with Sol-1 last year and then the trial was modified with a new SPA. So both may be accurate!
My recollection from other parts of the presentation was in alignment with slide #57.
Lastly, regulatory risk is primarily due to no SPA and no one having yet had a drug approved under the new guidelines. I don't consider the risk to be much different than many other FDA approvals, again waiting to see if there are significant design changes or warning more strongly worded.
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