Thursday, August 08, 2019 11:06:07 PM
I think this is war. Let me explain my thoughts:
1) Thero opens up the CC with throwing FDA under the bus, by saying that they asked him not to PR the news until FDA uploads it into their stupid registry. Thero could have kept quiet about it (he never mentions communications with FDA) but he spoke out.
2) Amarin FOIA'ed the fck out of all interesting players. I was perplexed when I first saw Nissen's name mentioned, I am even more perplexed now. You don't do this if everything is roses and rainbows - something is up.
3) FDA had 4+ months to request an AdCom. Why wait until now - hoping that the FOIA will shed some light.
4) FDA cannot get a goddamn panel until friggin November 14 - is that a joke? Hate to virtue signal, but people are literally dying - 20% RRR.
Someone needs to drain the FDA swamp. I don't think that Amarin can proceed at this point as if things are normal with FDA - How does that saying go: "fool me once, shame on you; fool me twice, shame on me"? Don't know what they will do, but walking into AdCom may be walking into an ambush.
1) Thero opens up the CC with throwing FDA under the bus, by saying that they asked him not to PR the news until FDA uploads it into their stupid registry. Thero could have kept quiet about it (he never mentions communications with FDA) but he spoke out.
2) Amarin FOIA'ed the fck out of all interesting players. I was perplexed when I first saw Nissen's name mentioned, I am even more perplexed now. You don't do this if everything is roses and rainbows - something is up.
3) FDA had 4+ months to request an AdCom. Why wait until now - hoping that the FOIA will shed some light.
4) FDA cannot get a goddamn panel until friggin November 14 - is that a joke? Hate to virtue signal, but people are literally dying - 20% RRR.
Someone needs to drain the FDA swamp. I don't think that Amarin can proceed at this point as if things are normal with FDA - How does that saying go: "fool me once, shame on you; fool me twice, shame on me"? Don't know what they will do, but walking into AdCom may be walking into an ambush.
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