This misunderstanding of the time for data analysis and unblinding, along with what he/she said about a lack of understanding of overwhelming efficacy rate vs efficacy rate "I don't understand why you think we might reach it at a later readout though, the efficacy is unlikely to change ?" leads me to believe that we are talking to someone either intentionally or unintentionally obtuse.
For everyone speculating on the time needed to recruit, if you were following when the hospitals started recruiting and how quickly they came online, there were not so many recruiting at the start and then it escalated over time, which would also mean the same for the rate of recruitment.
In terms of following the recruitment and speculating on when the 30% readout might be, here are my research and thoughts (though most of this has been stated many times by posters here, it is getting harder and harder to find these links and information on search):
1) One thing that is very seldom talked about around here, is that there is a delay between a hospital coming online for recruiting and when the first patient can be dosed. In the MSB announcements, the first hospital was marked as recruiting on May 1st and first patient dosed notice was sent on May 6th (though there could be a press lag there too). However there is a practical delay between a hospital recruiting and dosing being started. Even something as simple as having a willing patient that gives consent to trial involvement.
2) There were 6 initial sites recruiting, and then within two weeks the number of hospitals registered went to 15, but only a couple of the new hospitals were initially marked as actively recruiting. It did take a bit of time (on the clinical trials site at least) for this number to increase and for the number of recruiting hospitals to get up to the 15 actively recruiting sites we have now. You can see the trial details here: https://clinicaltrials.gov/ct2/show/NCT04371393
and browse the change history to see the changes in hospital recruitment here: https://clinicaltrials.gov/ct2/history/NCT04371393?A=8&B=9&C=merged#StudyPageTop
This is useful because you can see when the hospitals came online, and when they started recruiting. Many of them did jump on board in early to mid May, but a few only signed on in late May, early June.
3) There is a huge unknown with patient inflows into the recruiting centres, how many people are electing to participate in the trial (people can object for many reasons, for example relgious reasons) so anyone saying they are completely confident that the 30% readout date has been passed is either wrong or lying. Definitely though, if there is no news released as we approach the time frame that MSB gave for the study to be completed the 30% efficacy result looks less likely. Whether we are at that point or not, depends on your own analysis of the above data.
4) The time it takes to get the 30% readout is comprised of: recruiting the first 90 patients, dosing those patients, recording results, unblinding the results, analysing and collating the data, submitting the significance of the result to Mesoblast, if the result is effective then preparing an ASX statement. Some fo these can be done quickly, but not instantly.
5) Even if overwhelming efficacy is not achieved, regular trial efficacy (ie. passing the phase 3 trial) would still be an amazing result and send the shares soaring. We here at cot copper have possibly over-frothed ourselves collectively on the 30% readout possibilities to the point where we would be collectively disappointed by a regular phase 3 100% readout success story. I am not personally in that camp, a result in August at 100% of trial participants would be amazing.
About now is when I'd expect to hear if we got 30% efficacy. Some time in early to mid-July. So let's see, and then let's see again for 45% and 100%! It should be a fun ride!
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