Dreamnig yes. It's no wonder the stock dropped so significantly upon FDA question. There was, IMO:
- An absence of multi-factorial combination analysis of other factors influencing cytokine responses - which, IMO, is a huge concern. I mean, how can you be sure your product is doing what you claim it does, without exploring the alternatives?
- Inability to describe how and why exactly the mechanism by which immunomodulation actually occurs. This is a little mind numbing.
- Inability to describe exactly how MSB can rigorously and competently in view of latest findings of heterogeneity in bone marrow, ensure treatment consistency/potency.
- Inability to describe something simple like how long the treatment actually exists in vivo !
IMO, MSB have essentially blundered into a new world of medicine, don't fully and completely understand how and why things work. But can tell you "well it does work, and it appears to be safe. for now". The FDA have approved many treatments in the past where things have appeared safe, only to realise how wrong they were a little later.
Is the risk worth the reward for sick kids who have 80% mortality? probably. but that's a very specific cohort.
I'm a little shocked at just how little is known about the mechanism of action.
If the FDA approve, it'll be out of desperation. And i suspect they'd do it very very begrudgingly.
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