Re: Statistical Considerations
in response to
by
posted on
Mar 09, 2018 08:26AM
We have now 6 postive DSMB recommendations to continue with the trial as is , no SAFETY concerns or Efficacy issues after over 2 years of dosing, The DSMB could have easily pulled the plug at anytime if they saw any safety concerns ie alevated alts , or if the data did not show any promise whats so ever, Then after 2 years the FDA approves US site for the trial, . Before approving the trial did the FDA not see the trial results before making that late decision to add US patients ???( maybe the FDA did not want to be late to the party) Then we have Hepalink in December making their very large investment/gamble on the trial, Were they privy to see more data from management that made thier decision easy to make, Did Hepalink see something they liked before makeing that $100 million investment or was it just a hunch that maybe the trial will work.
I tend look at things half glass full but maybe my rose tinted glasses are fogging up my view. I hope this trial comes very close to the post hoc analysis results but I tend to think it might.....