Friday, March 11, 2022 1:37:56 PM
Interestingly though, I dug that same PR out not too long ago and reposted it too. And now that you brought it up again, and we have recently discussed this and the TFF potential manufacturing changes during the trial, I have a lingering question about the timing of the change in the trial from phase II to phase III. Do you know when that occurred as it relates to these two significant manufacturing changes? Was it in 2014? Usually, you would not implement manufacturing changes (unless it’s safety related) during one phase of the trial as that could potentially impact the results, so manufacturing changes are normally implemented after one phase has been completed and before another phase is initiated (or before commercialization).
I have thought that if those manufacturing changes were made, it would have occurred in this trial between those phases, and maybe that’s part of the reason why some refer to, and are watching, the last hundred patients or so. This has probably been discussed I’m sure, and I understand one reason is due to the additional 17 treated patients in the treatment arm vs the placebo arm. One question that I’ve had is if one or both of the manufacturing changes were made, along with the sicker patients that were enrolled at the end of the trial, if that is what potentially forced the imbalance of the two arms at the end of the trial. What do you think?
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