And another autologous cellular therapy approved by the FDA. The door is wide open for OCC to walk through with a well trialled autlogous stem cell therapy, without the potency assay contentions of theapies like MSB's. The FDA has been showing itself very open to autologous cellular therapies. This is a defined change to pre-COVID.
https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-mb-106-for-waldenstr-m-macroglobulinemia
I know investors are sick to death of hearing me and a "very excited" CEO, but the regulatory environment for ATI is much improved. Fingers, toes and any other extemities crossed that J&J sees this and joins OCC in a phase III partnership with OCC in the US, for a very now much more established and trodden path to approval in an autlogous cellular therapy.
And another autologous cellular therapy approved by the FDA. The...
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