...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: If BP buys Apabetalone,...
5
Nov 05, 2019 08:32AM
6
Nov 05, 2019 08:50AM
8
Nov 05, 2019 08:58AM
6
Nov 05, 2019 09:15AM
4
Nov 05, 2019 09:24AM
5
Nov 05, 2019 09:48AM
7
Nov 05, 2019 12:39PM
3
Nov 05, 2019 01:44PM
3
Nov 05, 2019 01:57PM
3
Nov 05, 2019 02:02PM
3
Nov 05, 2019 02:17PM
5
Nov 05, 2019 02:17PM
2
Nov 05, 2019 02:34PM
3
Nov 05, 2019 02:43PM
6
Nov 05, 2019 03:10PM
2
Nov 05, 2019 03:20PM
2
Nov 05, 2019 03:23PM
3
Nov 05, 2019 03:44PM
3
Nov 05, 2019 04:09PM
1
Nov 05, 2019 04:30PM
2
Nov 05, 2019 04:46PM
6
Nov 05, 2019 05:05PM
3
Nov 05, 2019 05:06PM
7
Nov 05, 2019 06:20PM
2
Nov 05, 2019 06:57PM
1
Nov 06, 2019 07:18AM
2
Nov 06, 2019 09:06AM
1
Nov 06, 2019 09:27AM
2
Nov 06, 2019 10:02AM
7
Nov 06, 2019 10:45AM
5
Nov 06, 2019 11:06AM
2
Nov 06, 2019 11:15AM
5
Nov 06, 2019 11:24AM
2
Nov 06, 2019 11:58AM
7
Nov 06, 2019 12:30PM
10
Nov 06, 2019 12:42PM
3
Nov 06, 2019 03:53PM
2
Nov 06, 2019 09:03PM
5
Nov 07, 2019 02:02AM

Those are my thoughts too Paladin. 

The FDA will have a hard time coming up with reasons to ask for bolt on data as a requirement for NDA filing.  My scenario depends on a) Lipitor/Crestor groups showing statistically similar outcomes, b) renal and dementia sub groups working out, c) the Forest plot being as stunning as Don McCaffrey is hinting, d) only the primary endpoints did not meet the target on a purely statistical basis (I can't figure out what Don meant by "narrow" margins), but everything else worked out as expected.  We already know that the drug is "safe enough for chronic drug use"...which takes care of the FDA's #1 concern (i.e. bad headlines).

I know people think the FDA can't approve us unless the 95% CI threshold has been met, and therefore it is back to the drawing board for more data as far as RVX is concerned.  But I believe the FDA's recent behavior shows that it is itching to approve new drugs.  We have huge needs with a rapidly greying population in the entire Western world.  RVX is by far the best buy 1/get 2 free drugs relatively quickly/plus many more in future free drugs, in front of the FDA.  The only concern may be that the FDA is not sold on the idea of Epigenetics.

My most likely scenario is that the FDA allows RVX to file for an NDA and may add proviso for extra trails and monitoring along with the approval.  So November 14 market action may be a bigger tell than Nov 18, IMHO.

3
Nov 07, 2019 08:14AM
2
Nov 07, 2019 09:00AM
9
Nov 07, 2019 10:42AM
2
Nov 07, 2019 11:06AM
3
Nov 07, 2019 02:02PM
5
Nov 07, 2019 04:39PM
3
Nov 07, 2019 05:40PM
5
Nov 08, 2019 08:31AM
1
Nov 09, 2019 06:10PM
2
Nov 09, 2019 09:09PM
2
Nov 09, 2019 10:02PM
6
Nov 10, 2019 08:37AM
5
Nov 10, 2019 09:23AM
7
Nov 10, 2019 10:17AM
Share
New Message
Please login to post a reply