Thursday, May 17, 2018 10:54:38 PM
I mean no offense, but do not think a sophisticated and challenging regulatory review such as NICE would begin this stage of review with blinded data. The first submission may include batch validations, process quality and other manufacturing data such as stability measures, but I think unblinded results would need to follow quickly behind as there is no point evaluating something that does not work. The NICE as far as I understand adds a unique review of pharmacoecomic data. This type of information would likely be provided in the later stages of a multi-step submission. Preliminary clinical results have already been reviewed thus affording the August opportunity which LP would be absolutely crazy to pass on.
I think we get a clear picture of timing very soon followed shortly after by topline results to include both PFS and mOS outcmes. They were hoping to get an early pop from unblinded 2017 publication to raise the roof multiple times in succession but they didnt have the clout or luck to pull it off as it now appears. The may or may not provide deeper cuts initially, but likely this rolls out over time to maintain a drum beat of positive noise (or at least that’s how it is typically done by experienced marketer-research partners).
I will say that Imhave been sleeping easier and dreaming big again. Things are looking really upbeat right now to my watchful eye.
Here is to your Dendreams coming true in the near future for all longs. I smell the ‘Rope-a-Dope’ coming this round!
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