Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-493

Well I have come back to the board to try to synthesise what occurred today and honestly........super hard to say who's right and who's wrong. Because if it was that easy to know then we'd all be billionaires.

What I do know however is that going through an approval process isn't fun. So what has occurred so far is to be expected. The final outcome remains unknown. You don't publish giant neon signs saying "we are going to approve or reject" in released discussion notes.....

Nobody knows what the outcome will be yet. The FDA is simply doing what the FDA does. Asking tough as hell questions which spooks everybody. I've topped up today but it will be the last time unless we get an approval. If we don't then like most of us I'm definitely selling and walking away.

But at this point a top up and "waiting" seems like a decent bet considering MSB has (slowly) but surely kicked many goals along the way. its just taken WAY longer than we thought it would. Frankly I think the old timers on this board who have been here 6+ years myself included assumed MSB would be a winner or a loser by 2017/2018 and here we are in 2020 borderline 2021 and the question remains still unanswered.

Getting approved takes longer than people believe I guess. What occurred today is just another step in that process but we are almost at the final outcome.

BTW for those more clever and up to date than me can somebody tell me when the outcome is? I know the meeting is on Aug 13 USA time so does that mean we get a outcome next week? I doubt it.
My assumption is ODAC has to recommend to the FDA then the FDA provides their final YES/NO answer but that could easily be a month away? Or more.