Some thoughts from a friend:
Re BLA submission. Don't confuse a particular expected date of submission with whether the cells work and whether they'll ultimately be approved for aGvHD.
The BLA submission date has blown out in the past and the fact that we've had no indication that it has been lodged yet, with only 3 days to go til the end of the quarter, means there's an increasing likelihood that there could be another delay. If there is a delay, it might only be a few days or a few weeks, or it might be longer - we'll have to wait to see.
Maybe it'll be submitted on time, but Meso has a tendancy to let timeframes blow out without prior warning. That's my only concern - not whether the cells work. So, it's not a major concern as it may be just making absolutely sure the submission is approveable now that we have Dr Phil Krause (ex-FDA) looking it over, or it may be that the FDA's rolling submission proces and informal guidance have led Meso to do some extra work on one of the modules.
I really don't know what's going on, but I do know that Dr Kurtzberg fully supports Meso as the only treatment for these kids aged under 12, and also that Meso's Ryoncil is better tolerated and has much better efficacy and less side effects than alternatives for people aged over 12.
Please note the exact words SI used in the last conference call:
"Remestemcel is in line for a BLA resubmission, which we expect to be filed this quarter".
That's an expectation, NOT a promise and NOT a deadline. He always gives his best guess, without hiding behind the usual corporate "underpromising and overdelivering" - which is really just a way for CEO's to set up expectations which are easy to beat. SI wears the cost of his honesty and can't control the problems of dealing with a monolithic, bureaucratic and underfunded FDA, which means delays are common.
Lots of things can change to amend such a vague "expectation". I would personally hope that Meso would update the market before the due date to avoid all of this hand wringing.
So, if there is a delay, to SI's "expectation" I won't be getting overly upset, even if we don't find out until after 30 Sep. It is potentially poor shareholder communication, but that's about all at this stage.
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