Leucid Bio Granted MHRA Approval for Lateral NKG2D CAR T-Cell Therapy LEU011
You absolutely need to know about this!
It’s happening folks, our worst nightmares have transpired
I’ve been banging on about how MHRA changed its regulations in January 2022 so that advanced therapies (cell & gene therapy and tissue engineering) could be carried out in hospitals. This is a previous post on the topic:
Subject: FOI request and open letter to MHRA—please share far and wide...
Just sent this to MHRA I’ve just sent a FOI request and open letter to MHRA, see below: Subject: FOI Request—substantial change in 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors: PART IV “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products (ATMPs)”
Ian Rees at MHRA asked me for a Teams call to discuss, rather than do it over emails (wonder why?). Anyway, I had to agree and he could not answer most of the questions I asked him. At the end of the call he said he was about to retire, and hey ho, here he is as a consultant.
I then submitted a question to MHRAs March Board meeting, where subsequently Dr Laura Squire attempted an explanation.