...also, check out the note on the CLBP clinical trial site...

...also, check out the note on the CLBP clinical trial site regarding expanded access. If this is a protocol that permits analysis & has been run past the FDA as well, then this is very interesting.





This information is only apparent in the Study details on the clinicaltrials.gov site. Link here

So it may be, and this completely left field stuff on my part, that Mesoblast is planning to:

(a) use existing manufactured product - for which they have previously been given an FDA signoff on potency - to underpin this Expanded Access Protocol while the full standard approval trial is up and running under strict controls,

(b) have a deal with, say, Tenet (or other SurgCenter principal mediated intervention supplier) for the treatments & for any participants accepted under EAP to be subject to the same I/E criteria that apply in the RCT, but have their results not subject to any aggregation requirement under the protocol;

(c) under the deal have all data agreed to come back to someone the Data Monitoring Committee (and the FDA, probably) is happy won't compromise the double-blinded RC trial; and then

(d) have that someone analyse the outcomes of the EAP, on a patient by patient basis, and advise Mesoblast if a significance appears to show up that Mesoblast might want to forward to the FDA prior to the top line standard trial results, i.e. as providing support for a Type B meeting.

or something like that. And THEN the FDA may have enough before it to consider expressing its early support for an accelerated approval for Rexlemestrocel-l for CLBP.

Complete speculation on my part. But I find myself thinking why have the EAP otherwise? I mean, it is a great promotional tool, but I think running this in tandem makes some sense to me.

Food for thought.

Cheers all