Replies to post #59179 on Anavex Life Sciences Corp (AVXL)

[SquealingSquid]

Yes I think off label use is allowed as long as a doctor thinks it's necessary, but I'm not sure if it is allowed on a drug with orphan drug designation

[Aero-man]

Basparks79, I think many understand your frustration in trying to make logical sense out of a program designed by a government agency – trying to understand the UN-understandable is an exercise in futility and will probably drive you mad. Real world companies and people are forced to play these bureaucratic games the best they can and hopefully things end up in a somewhat positive/reasonable fashion.

A lot of these programs are designed by the government (FDA), for the government (FDA) benefit.

[TrueTrades]

Re: Your question

Way too many variables to hypothesize! They could have applied and were denied. Perhaps long ago, before Missling arrived. Focusing on AD could make lesser indications out of scope. Interest from outside sources can guide pathways...etc, etc.

It is one of the things that is generally outside of the shareholder info, specific actions that are better kept under wraps by the co. We just don't know until an announcement.

Likely there is an outside influence on the Rett syndrome developments. A3-71 in an OI is likely the quickest way to get it to market, where obviousness and changing off-labeling rules will have it prescribed for other inds. Yes, a doctor can essentially prescribe anything for anything, it's whether 1 or 10,000 are doing it that causes issues.

This site has lots of info:
http://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=778

If the co has meet with the FDA and the guidance that they received was weighed heavy towards safety info and providing expanded PK/PD data for a "we got your P3" type trial, IN LIGHT OF APPARENT EFFICACY AT 12 WEEKS, we have a home run. The FDA will be indicating that long term safety is the only real hurdle to a new SOC.

If we are not getting the 12 week update until May and it is very promising we will probably see a RPRX-type move. $12 - $14

This is certainly looking like some partnerships will be developing, if nothing else!


BUMP! Reyeton's post :-)
GO LITTLE REDHEAD!!!
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