RE: PIND meeting1 Mar 2023 06:43
Is it just me or Laserbrain a carbon copy of Stu? Anyway moving on.......
Taken from RNS on 29th Sept 2022. (After reading this, I'm sure you would agree that there is no need to RNS about a meeting with FDA - they have clearly articulated formal engagement with FDA. No need to have to tell investors that they have had a meeting with FDA - they had already said they were in the final stages 5 months ago. It's also fair to say that it has been voiced that the PQ runs were the last big step)
HEMO-CAR-T, a CAR-T therapy targeting Acute Myeloid Leukaemia ("AML"), is our lead product candidate, the intellectual property and development of which are in the Company's sole control. We have been working toward completing the necessary IND application for HEMO-CAR-T, having held detailed discussions with the US Federal Drug Administration ("FDA") during the period and received constructive feedback through a pre-IND submission that confirmed our development process and our proposals for clinical trials. Most of the data required for the IND application has been compiled and the components for manufacturing HEMO-CAR-T have been produced. We are now engaged in the final stages of establishing the production of HEMO-CAR-T cells for the treatment of patients. We are confident of completing the IND application in the near future and are working on detailed protocols for carrying out clinical trials.
The work is necessarily very detailed as the main concern in the process is to ensure patients' safety, which requires great care on the FDA's part and of course ours. We have been working with a group of Key Opinion Leaders in the treatment of acute leukaemias that has helped us to hone our approach to clinical trials. We are now in the process of finalising our trial protocol, which will involve a relationship with at least one major hospital, likely to include the University of Pennsylvania with whom we already have a working arrangement.