RE: When will the Covidity Safety Data be revealed ?10 Oct 2021 16:26
Chester,
I'm sure that any interim reporting would include safety. We might just get a very general statement such as 'SCOV1 was well tolerated with no serious safety issues' or they might give more detail, I just don't know. Would be fantastic if we also get details on T cell and antibody responses but again that may be simply a general statement rather than detailed data.
As for timing - 2 weeks after last patient dosed might be optimistic. Producing data of high quality and integrity is vital and probably takes far more work that most of us realise. Data needs to be collected, verified, missing data identified and chased up, any anomilies sorted out etc. etc. so that the database is complete and clean. Sounds simple but have a look at the trial endpoints and imagine just how many data points there are. They need to make sure that each and every one is there and correct. Even one missing temperature or blood pressure reading for one patient needs to be spotted and sorted out. Apparently the average clinical trial generates over 3 million data points, and then of course it needs to be anlaysed. I really haven't a clue whether it's realistic to expect that to happen within the space of a couple of weeks..
Finally, your last question was about speed of recruitment. Remembering that these are healhy volunteers, I expect that they'd recruit, screen and dose quite quickly. It would be interesting to know how many have now received their first jab