Ok no surprise so far. "We look forward to working closely with...

Ok no surprise so far.

"We look forward to working closely with the Agency over the review period with the aim to make remestemcel-L available as a therapy for children suffering from Sr-aGVHD said Mesoblast Chief Executive Siviu Itescu."

Okay but what does that look like in practice? When is a site visit scheduled for instance?

No comments on - why FDA took this long to respond (greater than 14 calendar days) or if the FDA has provided feedback on IND file update. No comment on whether the BLA was filed immediately MSB resubmitted it or whether any clarifications were sought that extended the SOPP guideance time.

FDA granted remestemcel-L Fast Track designation, a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs, and Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments".

Okay - but the PDUFA data is six months anyway. So has Fast Track helped? No comment has been made on whether the FDA is actually doing any rolling review of modules.

I'm not expecting another ODAC meeting.

In my opinion - then next major announcement on this is still more likely to be a complete response letter at the PDUFA date than a granted BLA.

Stand by for a lot of no news in my opinion (on the BLA resubmission) until August 2.