Thanks for all the good info in this thread guys. Much better...

Thanks for all the good info in this thread guys. Much better than the raging binfires elsewhere.

A couple of quick observations on MSB communications. Hindsight's useful, but I can't help feeling some of this pain might have been averted with an expectation-setting ASX release on Monday stating:

• It is normal that any drug or therapy, including a novel therapy such as MSCs, receives strong scrutiny from the ODAC and FDA. That's something we believe is important and welcome. We have been responding to/working with the FDA since submission of the BLA
• Under the normal process, the ODAC will release the agenda and their questions early this week ahead of the meeting; they'll also release our preliminary responses.
• We will get the chance to update and expand on those responses during these sessions, along with addressing any outstanding queries. Because this is a novel therapy, there will be two sessions instead of the normal one session.
• We will be pointing to the safety, efficacy and manufacturing consistency of the product support by the data from the single-arm trial, Japan, etc etc

However, I complete understand that this is a rare company in that 80% of its value is tied up in its relationship with one stakeholder - the FDA - so if that kind of approach in any annoyed the FDA or breached its protocols I can see why they wouldn't do it. Better to just take the pain on the market and move on.