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Post by biotec on Mar 31, 2014 13:18:32 GMT -5
Was just listening in on the DRTX adcom to get a taste of the Q's. I hope MNKD drings all there fire power. Some very detailed Q's
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Post by biotec on Mar 31, 2014 13:20:36 GMT -5
Heres the link if interested
t.co/9eo1RaLHdA
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Post by esstan2001 on Mar 31, 2014 15:55:51 GMT -5
On a brighter note:
I listened to this AdCom meeting from ~3PM on for approval of their antibiotic today... sounded very iffy when the FDA lady spoke regarding efficacy and safety.
Then at about 4PM the vote occurred- was 12 0 to approve.
Go figure.
Sure hope that is how tomorrow goes.
GLTA
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Post by alcc on Mar 31, 2014 16:26:25 GMT -5
Who is going to respond for MNKD? DO we know? He better be on his game.
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Post by brentie on Mar 31, 2014 16:41:31 GMT -5
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Post by biotec on Mar 31, 2014 16:56:43 GMT -5
Thanks Brentie.
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Post by alcc on Mar 31, 2014 18:49:35 GMT -5
So Robert Baughman is our man?
And Lisa Yanoff the reviewer whose comments dripped hostile cynicism?
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Post by biotec on Mar 31, 2014 18:58:27 GMT -5
Lisa is speaking on behalf of the FDA
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Post by babaoriley on Mar 31, 2014 18:59:15 GMT -5
Check Lisa's (Swiss) bank account, living arrangement, automobile, etc.
I'm sure we will be well represented and we will get across how effective Afrezza is. I wouldn't want to be around Al right about now, he cannot be too happy with these shenanigans.
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Post by alcc on Mar 31, 2014 19:06:46 GMT -5
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Post by alcc on Mar 31, 2014 19:14:09 GMT -5
Interesting. See post by MNKDFAN re Victoza that I cut and pasted below. Crappy adcom vote and safety concerns. Yet FDA approval. Does being NOVO make a difference? +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ Alcc, perhaps a closer look at Novo Victoza Adcom vote and BD will be a better comparison. Below is a link to the BD, adcom vote, and FDA approval letter. www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4422b2-01-fda.pdfwww.fda.gov/newsevents/newsroom/pressannouncements/ucm198638.htmwww.firstwordpharma.com/node/358352?tsid=17#axzz2xUYCtdJPThe Adcom vote outcome was unimpressive to say the least (8:5 for cardiovascular risk) and (6:6; one abstain for cancer risk). Although the big red flag with Victoza is around the cancer and numerous safety profile, it also had minor issue in the statistical analysis of the efficacy result for one of the dosage (pg 59/60 statistical review). This is what one of the reviewer had to say: "FDA staff reviewers noted that cancerous thyroid tumours were observed in animal models administered Victoza over a two-year period, and they indicated there was not enough evidence to rule out a risk to humans. Panel member Peter Savage commented Thursday that "the animal data is worrisome, and I didn’t see sufficient human data to feel reassured...I’m also not convinced that the benefit of adding this drug with the risk at this time outweighs the tradeoffs." Needless to say the FDA proceeded to approve Victoza a short time later in 1/2010 and sales for Victoza is approaching $2B for 2014. Regardless of increasing evidence of patients using this drug coming down with Pancreatic cancer and call for it to be removed from market along with the nasty label warning, Novo will continue to be successful because type II will do anything to avoid or cut down on having to take three shots per day. I had my finger pricked twice to measure my glucose before/after meal and cringed like a little girl. I think MNKD will be a major success in type II patients because it will provide the "SAFE", effective, and convenient (painless)alternative for type II patients. www.webmd.com/diabetes/news/20120420/consumer-group-to-fda-take-victoza-off-marketBesides, we can't have Spiro go on a witness protection program to hide from his wife if MNKD fail for the 3rd time  . Looking forward to the vote response on Tuesday!!!! MNKDFAN Read more: mnkd.proboards.com/thread/595/adcom-review-comparison-mnkd-chtp#ixzz2xaYxq91z |
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. Looking forward to the vote response on Tuesday!!!!