"Actually I wish I had the chance to do their announcements for them."
OK, these are some of the factors as I understand them, that underlie the reason Mesoblast cannot put a specific date to their meeting with the FDA.
The trial is run by the Cardiothoracic Surgical Trials Network (CSTN) with funding from various public bodies as previously stated. Reading the stated Goal of the CSTN it seems it is not within their ambit to commercialise products (e.g. meet with the FDA to pursue a BLA etc).
SI has made it known at least once IIRC that Mesoblast will not have access to the full dataset till the trial results are published, i.e. in a journal. That is the lead investigator (I guess) will write up the results of their trial. With about 20 investigators (slide 16) it might go through a few revisions, and then it is submitted to one or more journals for acceptance and usually subject to peer review prior to publication.
A search in Google Scholar and on the CSTN site does not show any pertinent publications beyond the P2a study, originally published 28 Mar 2014, as a follow up to that trial it may be received more favorably in the linked journal.
Mesoblast has no control over when the investigators will complete writing up their results to their satisfaction nor over precisely when the journal article will be published. That is why I believe they cannot specify a date for the FDA meeting, nor do they have control over when the FDA will choose to schedule the meeting to discuss the results.
On publication Mesoblast gets access to the full dataset and they can book the meeting with the FDA. That meeting will be a follow up on their June 2018 meeting with the FDA when they originally discussed a possible regulatory pathway for MPC-150-IM in an LVAD population (slide 9) where the FDA indicated "Non-surgical GI bleeding and/or epistaxis are clinically meaningful issues for patients with LVADs and represents an unmet clinical need."
Yes maybe they could have said more in the Newsletter about why all they can do is plan the meeting will happen In the first half of 2019.
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