Post by
loveshackdave on Jan 15, 2016 11:40am
FDA falling behind
Review of SUSTOL delayed from Jan 17th to late February. Maybe the MCNA review will be delayed too? "Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016. " https://www.businesswire.com/news/home/20160115005119/en/Heron-Therapeutics-Notified-FDA-Action-SUSTOL%C2%AE-Drug
Comment by
ragingbull1234 on Jan 15, 2016 12:24pm
Yep. I didn't even know that, but I assumed it. Nice to see that the FDA themselves admit it
Comment by
ragingbull1234 on Jan 15, 2016 12:26pm
If they think that they are inundated now, just wait.....and wait some more. By 2018, it should be physically impossible for them to keep up with anyone submissions. Time will tell, but don't be surprised if I'm right. If if it makes you mad
Comment by
ragingbull1234 on Jan 15, 2016 2:09pm
My real opinion is that they're sucking this badly on purpose. No one can innately suck this bad. No one. Even in Bangladesh
Comment by
ragingbull1234 on Jan 15, 2016 2:10pm
I also wouldn't be a bit surprised if the FDA themselves troll this message board instead of doing their jobs. :)
Comment by
ragingbull1234 on Jan 15, 2016 2:11pm
Approval today? No? I didn't think so...
Comment by
ragingbull1234 on Jan 15, 2016 2:15pm
Apparently you didn't get my recurring memo. I'll leave the public forum when the people you continue to glorify and count on FINALLY come to a decision. Not before. End of story. Send your complaints to them. Until then, piss off
Comment by
ragingbull1234 on Jan 15, 2016 2:25pm
Yes or no, hell or high-water, Feb 27 or before. Once they release their decision, I'm gone.
Comment by
ragingbull1234 on Jan 15, 2016 2:27pm
If you're really as upset with my posts as you say you are, I would seek therapy for your disstress. Then I'd tell the FDA about all of my "bothersome" posts, if they're not already aware of what I think of them and their process. Other than that, I imagine you will see me here for another 45 days or so.... Relax bud
Comment by
ragingbull1234 on Jan 15, 2016 2:40pm
CNBC actually thinks oil is down 5.7% because of CHINA??? Pffft. Oil sucks because it's OIL. ha. China. Cmon! Make the story BELIEVABLE at least.
Comment by
ragingbull1234 on Jan 15, 2016 2:42pm
So if it's China's fault today, whose fault is it going to be when it hits $18-20 a barrel? China too, I suppose. China China China. Haha
Comment by
ragingbull1234 on Jan 15, 2016 3:01pm
(Not our CEO, I mean the average CEO, or worse). As far as CEOs go, this one is the best this company has had I think. Haven't seen his Lexus yet anyways.