I think the problem is the opposite - they were not ignoring the results in particular the past failed results and the FDA even said as much " We cannot ignore the past trial failures ". In the FDA mind, they do not understand how a drug could possibly work with children but not at all in adults for the same disease, and they have basically all but disregarded the companies explanation on the link between TNFR1, outcomes and manufacturing improvement timeline.
I can't help but believe that had we presented this trial only - without any past history it would be approved on the basis of demonstrated efficacy and safety in children.
The plus side is that now the only product available is the " new " product, then all new trials going forward will be the best they can be, including COVID ARDS, which should have a better outcome than the best possible GvHD trial with the cells going straight into the lungs on injection.
COVID ARDS trial also has no past failures to cause concern, so a positive set of results in adults should result in immediate approval, and backup the TNFR1 inflammation argument.
Need to remember that nothing has changed from a result point of view. The SRAGvHD trial was still a success... which means any further failures ( even Covid ) with the same product would cast a massive cloud over the proposed MOA. Given that DSMB has not halted the trial due futility yet, then it should have seen separation between treatment and standard of care.... so this shouldn't happen.
Aside from the delay, the real downside is the SP today and tomorrow because now the games will start being played again , right up to November and the phase 3 readouts or Type A product sale approval ( if that happens ). May even float down into the 2's with the downramping that is going to happen.
All this really does is mean that November and those phase 3 results are going to be even more crazy. We don't have success planned into the current pricing for GVHD, and we don't have COVID, Heart Failure or Disc regeneration either. We still have massive upside and downside potential, just all jammed into roughly November now
MSB Price at posting:
$3.27 Sentiment: Buy Disclosure: Held
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