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Wednesday, January 16, 2019 6:55:34 PM
So I'd have to argue that with management having released that PR, they have already been advised by the advisors and have made their decision. As for the whole of the data, they already looked at it - twice. They chose to wait in 2017, and with the 2018 data, they decided to move forward.
It is up to them, not Management, to recommend unblinding based on the whole of the data.
However, there is a lot of wiggle room they left themselves in that PR, and that is what I'd like more public clarity on. If there are certain stages that are done at the same time, which ones are they and how long do they take? How far along are they? Is the SAP finalized?
These are questions that can be asked. I believe you are a lawyer (by your posting name, and your writing style), so you likely know they know how much detail they can give us to answer that question. They should be prepared for questions like that... in other words, they should know they are coming. They can choose to answer them or not.
It is a matter of looking at the data as a whole (as was stated during the proxy meeting in April 2018) and making a determination based on knowledge and experience in the field whether or not the data is sufficient to get approval and show what the treatment is capable of achieving.
My point here again is that they did look at the data as a whole and made a determination that this IS the time. I know I, for one, would just like more clarity and detail on that topic. You know, something like...
We anticipate
(and frankly, they should have an idea by now as it's been two months since they began including November)
unblinding between blank and blank,
with top line to follow between blank and blank.
And hopefully the between blank and blank will be more accurate than the business matters we were told would be coming in a matter of weeks, and instead we heard them 6 months later.
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