I would love to have more context around the recent IDMC review of the GvHD trial. What did the FDA actually say? We’re the proposed protocol amendments accepted wholesale, or were there negotiations? How did they agree to the shortened time frame of 30 days post-treatment? I doubt you’ll get answers here, but I’d love to ask the questions.
Beyond that, I’d want to ask about:
- Funding... but you won’t get answers. Same with acquisition details, starting cancer trials, further thoughts on MS, etc.
- More details on the plan for increasing dosage in mono. Do they have another soft target for efficacy from the FDA? How many do they expect to enroll new vs. convert from lower doses? Expect a 48-week observation will be necessary again? Would 48 fresh week’s be required for converted patients?
- When do they expect to have a meeting with the FDA regarding investigational vs. pivotal for mono?
- What specific CMC issues do they expect to encounter for combo BLA?
Appreciate you making the effort, and I look forward to hearing how it goes if you have a chance to discuss things with him.
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