Has the company even taken this action to collect data for 42 and 60 days? They did not follow the recommendation of the DSMB in any press release I have seen. Since the DSMB recommendation, I have not seen the company is pursuing this. They might wish they had or are now trying to figure out how they can do this. It would not be difficult, but I have not heard nor seen a press release they are. I think this data would increase the p value but it's not an end point of CD12. So, how do you change the endpoints of a trial that technically is complete? Maybe THESE results are where they can adjust and follow the DSMB recommendation with the addition of 60 days? (doing what could have been done at 75% enrollment). Lot's of data coming from the OLE and EIND patients. I am reasonably sure this data is being looked at by the company and FDA as well, but this process projects a thought that some decisions regarding DSMB recommendations is an error. DSMB is there for a purpose and if you cannot trust their insight and recommendations, well........... The only reason this causes me anger is the product works and it seems the inexperience of someone or many are their own worse enemy. What is also "fact" is, 24% increase in saved lives is SUPER. Out of hospital 6 days sooner beats the SOC with statistical significance .005!!!(No statistician would call that failure, right?) FACT: Janet Woodcock stated, "anticipated P-factor as not reflecting the urgency of S/C need”, they would "take risk and award EUAs that showed good improvement" over SOC. THIS is how medical people think.
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