There is a lot to getting an NDA approved. Having Fast track means that Anavex can be working on those issues and submitting sections of and NDA before the full NDA is complied. That means that Anavex could already have submitted the manufacturing facility info and other sections for FDA scrutiny.
In the case of Rett the advocacy groups will be making sure that families of Rett girls know about 2-73 once it is approved. Insurance companies will have little choice about approving the drug for coverage since it will become the standard of care.
More likely Missling is thinking beyond just Rett and preparing for dealing with several approvals. Laying the groundwork Fragile X PDD etc.
Yes. As for "equity partnership" suggestion, there is little chance of that; a young biotech with heavy late-stage pipeline does not buy into other biotechs. Their capital budget is for trials and launch prep, as you note.
CARE TO RETHINKTHAT?: just because a drug is approved and distributed does not mean that physicians will immediately begin writing prescriptions and that insurance companies will be jumping all over themselves to provide coverage.
We're talking Rett here...you know, the Rett with no current treatment.
The Rett where parents see their girls suffer and boys die.
WTF else would parents do, not try to get 273 for their child?
C'mon man!
WTF else would doctors do...nothing when a safe treatment exists?
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