FDA announce new policy approach, page-32

Let me consult my crystal ball.

Depends on whom MSB are talking to, is it only MNK or are there others in the mix.

If none have agreed to the partnership conditions after the aGVHD trial 28 day endpoint is published as successful, 28 days after that last enrolment is done and infusions begun, then a partner should appear very shortly after distribution approval is given, or maybe before given the >240 people that have been treated in the ongoing expanded access program.

There seems to be some flexibility now, not sure if it applies to this kind of treatment, where the assessment of efficacy can be done post commercial release. With only 28 days to primary endpoint I suspect that will not be the case.

As to whether a partner for aGVHD will be enough to eliminate the financial dependence on the kindness of strangers, no idea, ask the CFO. That might have to wait until a second product is partnered but the raising of funds at that stage should lead to much less dilution.

Indeed they might even be able to do an IQE (LSE) and raise institutional funds at the closing price of the day before, wouldn't that be nice.