Cells sourced from other humans are treated as black magic by the FDA….there is no urgency clearly, given nothing approved as SOC by them treats this cohort humanely or effectively. So even a conditional approval is no awarded despite this cohort benefiting successfully for more than 3 years ????? Paraphrasing……therapy/ drug approved only if free? This EAP is additional to successful trial PE and a slew of other supporting data ? Really ? Yet the FDA has no issue with organ transplants & blood transfusions….they’re not strictly ‘drugs’ either but that’s ok. Short end of the straw for sure.
Ann: Change of Director's Interest Notice - Silviu Itescu, page-134
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