Friday, March 22, 2019 11:40:05 AM
I'll give you the benefit of the doubt since English is a second (at least) language. That's not a personal dig at you, by the way, as my secondary language skills would like only allow me to find a bathroom. However, anyone reading that statement is going to read it as an inability to find and enroll satisfactory patients - particularly after the saga of the combo HIV trial. That's simply pure, unadultered speculation at this point. This trial is incredibly important, has been put together at lightening speed, and it's a perfectly reasonable take to think that they're simply working to ensure that the trial and protocol are beyond reproach and that the FDA agrees with that prior to starting the trial. For example, they've already had one protocol change for the 1b portion, from dosing 6 patients in each dose cohort to using a 3+3 protocol for dose escalation, which may reduce the number of patients needed in the 1b by up to half. In the scheme of things, a month (or more) delay in starting the trial is nothing in comparison to having to amend the trial midway through - this could very well be an example of the company learning from their sins of the past with the HIV trials.
A case of NP being overly optimistic with public statements yet again? Most likely. If anyone hasn't learned to process his forward looking statements appropriately at this point, that's their own fault. A case of "trial enrollment failure?" Excepting my benefit of the doubt, that's an incredibly speculative statement.
I won't continue to argue the point.
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