""And you think IPSC's or Cynata "not even on the FDA radar". .
They aren't on the FDA's radar."
Wow. You show the same ignorance of your brethren.
No Pledge. Not on their radar at all. They just gave it orphan drug designation 2018 by error.Seriously showing your base ignorance again in the usual desperate unprovboked slurs.
The FDA's actual remit:
"FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health."Kind of why they give out orphan drug designation to CYP in 2018 (and to MSB too in MSC's). Because IPSC's are very well on their 'radar' and things you have probably never even hear of (until I mentioned above) like CRISPR edited IPSC's.
Yes Pledge, IPSC's are not on their radar at all and they haven't published various research articles on them:"Human induced pluripotent stem cells (iPSCs) have great potential in cell replacement therapies due to their ability to give rise to all somatic cell types. iPSCs can also be directed to immune cell types for immunotherapies against cancers or autoimmune diseases. The unmet needs in developing iPSC-based therapies include methods to evaluate differentiation efficiency and to characterize cell populations during differentiation."
FDA Office of Tissues and Advanced Therapies; Division of Cellular and Gene TherapiesGene Transfer and Immunogenicity Branch, March 2024
Your ability to show your ignorance on subjects (IPSC's and Cynata) you insist on lecturing on, is consistently astounding.
The FDA has not been studying and researching IPSC's itself. Its all just a lie by the FDA's CBER and the office hasn't for a while, been studying "cell fate determination of human iPSCs, with an emphasis on hematopoietic and lymphoid differentiation".
Oh and the FDA, didn't recently clear another important application of IPSC's for an IND last year, just as it has Cynata in 2022, nor Fate Therapeutics in 2020, nor Century Therapeutics in 2023, nor CRISPR technologies in 2020, etc, etc, etc:
https://pharmanewsintel.com/news/fda-clears-ind-for-new-parkinsons-disease-treatment-using-ipscs
Seriously you boys talk absolute rubbish in induced pluripotent stem cells and the FDA and Cynata.Here you go Pledge. Rather than just typing vitriol and ignorance on here. A little light reading for you, to educate you, on SOME of the various trials of IPSC's of significance - you will see Cynata features prominently funnily enough and is very much ahead of the crowd and progressed, contrary to your mate's idiotic assertions - rather than just typing stuff you know nothing about:
https://www.alacrita.com/hubfs/iPSC%20Clinical%20Landscape%20-%20June%202023%20-%20Alacrita-1.pdf
What? Cynata fully recruited Phase III when others still Phase I? Yes children.
(20min delay)