Definitely a huge blow to the company. SI is the lowest that I've ever heard on all the calls through the years but nevertheless sounds eager to get on with the work and get this product to the market.
My mind turns to whether the proposed adult trial may be powered with interim analyses similar to the ARDS trials which could accelerate the trial.
SI did mention they couldn't 'get on' with the adult trial in the meantime until the potency and manufacturing was ticked off - FDA is really ticking me off on this one.
I suppose longs may consider the pain too much and exit completely which is understandable - I'm considering accumulating further at lower prices dependent on guidance on the trial after the Type A Meeting in the next 45 days.
A bit like others around here, I'm not sure how happy the wife is going to be hearing the news.
Ann: Update on BLA for Graft Versus Host Disease, page-159
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