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meirluc

03/14/21 7:04 PM

#36185 RE: lightrock #36184

This could explain why rate of events corrected upon new mass enrollment



lightrock, please enlighten me on the rate of events that have been corrected upon new mass enrollment.

I only know that Geert stated in one of his recent videos that the trial was expected to end abou 2.5 years before it did and that in January 2019 one of the trial's reviewer (I don't remember who it was) believed that the trial will be over by the first half of 2019. AS we all know, data lock was only announced in early May 2020.

That does not seem to me to be a brisk correction of a slow rate of events.

Any major screw up of the first CRO would not necessarily result in an accidental slowing of events. I cannot believe the IDMC would not have been able to get to the bottom of that dilemma and would not have taken remedial steps.

I would also like to correct the third paragraph of my previous post 36183. It should say that of the 298 patients who died by the end of the trial, 175 (59%) were SOC and 123 (41%) were Treatment patients.

I apologize for having made this error.



meirluc

03/14/21 7:21 PM

#36187 RE: lightrock #36184

lightrock, I forgot to mention that the official rate of enrollment published by CVM states that 135 patients were enrolled between 2011 and 2013, 195 in 2014, 340 in 2015 and 260 in 2016.

While only slightly above 1/3 of the patients were enrolled before 2015, the midpoint enrollment for all patients was still quite long (63 months).

It is hard to imagine that more than 50% of the SOC patients survived an average of 63 months and remember that when the trial officially ended with data lock (May, 2020) the last enrolled patient was already enrolled for 3.5 years, at a time when the average death rate of SOC is already higher than 45%.