Marker Therapeutics Inc (MRKR)

[rwwest]

Redplate suggested that there may be a good side to the delay. No doubt though it is testing our patience a little.

"Peter any hold is for a real reason, and no they are not trivial. In this case it appears that the hold relates to third party suppliers of reagents used in the culture of T cells. The trial is designed to be a potentially pivotal trial if results warrant as a repeat of early results. Thus fully compliant processing is essential so that these results can be used for a potential submission. A delay yes. Resolution suggests that FDA will consider this 20 center study as potentially useful for an approval.
Compliance in cell therapy settings has been an evolving set of regulations at FDA with newer guidance documents describing critical reagents and processing needs for ‘single patient’ production. A struggle within FDA between the blood /processing regulations and the center for drug development. It’s been hard for companies to comply with somewhat conflicting regulations/guidance.
This is now evolving quickly in the days of CAR T cell therapies in particular with respect to reagents used that ultimately do not even end up in the ‘product T cells’. I will suggest that recombinant T cell products have made it harder for this less invasive/cell altering approach. As a CMC guy these issues are pretty straight forward after some vendor qualification work this will go forward with a greatly reduced risk that the trials results could be compromised.
Just my humble opinion of course"