Not always, but I try to - wasn't aware that it's common for people to skip mountains of posts, but it explains why I frequently say (or think) "we just talked about this last week, does everybody have short term memory problems?" - like the question about whether FDA looks at ability to meet demand when determining whether to approve an sNDA, NDA, or BLA - that was answered over a week ago, and it's NO. What they care about is the manufacturing facility's ability to meet their quality standards - that's definitely part of the process, and a large % of CRLs issued are due to failure to meet those standards.
My opinion of the board's sentiment is "oddly fearful" - it's like people are literally looking for ways to scare themselves into thinking we're near a high risk binary event - meaning many have forgotten the post AHA euphoria over results and "we crushed it, R-IT approval is guaranteed now!" - just bizarre. I think if FDA had come out and said "no Adcom" the sentiment would be way, way different, although we're way past any reasonable time for FDA to call for one - ask yourself why FDA would grant PR after reviewing the sNDA then postpone the PDUFA so late in the game - makes absolutely no sense.
P.S. Got a new email from my bro this morning - he's been diagnosed with FH - he's damn lucky to be alive, has not had well controlled LDL-C because muscle pain prevented his doc from raising statin dose - he also tested low for Vit D levels, so I emailed back with Vit D3 and COQ10 info, because his doc increased his dose of pravastatin substantially - also suggested he look at generic Crestor. He said his doc may be willing to prescribe V after the FDA changes the label. Not even going to bring up Zetia, PCSK9's, your regimen - I'm flooding him with too much info as it is, he's not used to dealing with all of this stuff that is totally routine for me (and you), meaning all of the blood tests, DS, and drugs that could help his treatment and improve his health. If I were him I'd want every piece of data I could get my hands on - made it to 60 with FH w/o an MI - a very lucky man.
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