My understanding is that the note from the FDA indicates that...

My understanding is that the note from the FDA indicates that they need to be convinced of the quality/consistency of the manufacturing process before that can give approval, something MSB have yet to prove to date. Do you think the FDA can be "convinced" during the upcoming meeting? Personally, I don't think so.

The FDA will tell MSB what proof they need as evidence of quality of the manufacturing. So following the meeting, it's likely the FDA will ask them to prove the manufacturing process and then come back. The SP will probably drop further if this is the case

So I'm out (very small profit), but will buy in again if the above eventuates once the SP has stabilised.

For those not sure on what to do - ignore anyone confidently saying buy or sell. And know that what is always true in trading is minimising risk. Its never silly to take some profits, reduce exposure etc. Playing the stock market doesn't need to be binary