Does anyone know if patients in the control group were told that they were in that group and asked if they want to cross over, or were they asked if they wanted to continue, and were assured they'd be continued on the vaccine.
The other question might be, were those on the vaccine asked the same question, or did they automatically just stay on the vaccine.
If it's clear that those in the control had a decision to make, it would also be clear that at that point the clinicians learned who were the control patients. The company wouldn't be told what they observed, but the clinician should have been able to clearly decern the benefits. The DSMB should have also seen the same thing.
At the time of the halt, I would have to wonder if some thought was being given to early approval, while they may have determined not to do it, they did simultaneously decide that all entering the trial would get the vaccine. I believe the regulators clearly saw the benefits and agreed to this change. I was not a shareholder at this time, it's just speculation on my part. Also, clearly back then if approval was a consideration they would have had to know that massive cleanroom construction would have been needed as FlaskWorks was an unknown at that time, I believe.
Gary
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