COULD THEY BE??? Could they be actually be using the tortuous (and torturous) initiation of this Trial to our advantage?
A consequence of insisting on a sufficient sample (say 25) before announcing 3-month complete responses following such a tapered lead-in will be that a significant number of those 25 (say 10) will by then also have received their second treatment.
Now let`s say that some of those 10 (we all hope that it will be none but it is possible that there may be some) fail to achieve a CR at 3 months`or achieve their CR at 3 months but without the attendant ’no clinical evidence or presence of disease’ and the second treatment delivers them the knockout blow.
There could then be an addendum to the 3 month results that might read something like this:
‘The first 10 patients in this trial have now received their second treatment and of the x number who still had a detectable presence of cancer at 3 months only y number/none now do so.’
There is already precedent to allow pre 90-day publication of second treatment status and that is the ann of Monday the 18th of April 2018 an extract from which read as follows:
‘The sixth patient’s 90-day cystoscopy analysis will be completed in May 2018 to rule out recurrent NMIBC. To date, the patient has shown no clinical evidence or presence of disease’
Was this whole long slow start deliberately contrived so as to conflate the benefits of the second treatment with the CR Results ?
Now that would be clever - but then they are quite clever.