Anavex Life Sciences Corp (AVXL)

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Off-label Therapies?

Dado, as a practicing physician, can you detail for us what’s involved in off-label prescription and use of drugs such as Anavex 2-73 — once it’s FDA-approved for, say, Rett syndrome (but no others)?

If off-label prescriptions yield very favorable results for a number of central nervous system diseases not included or indicated on the drug’s “label,” what might then happen?

What’s the chance that this might lead then to wide professional use of the drug, before specific FDA labeling for a CNS disease? “Hey doc, my kid’s got a rare CNS condition. Please, put him on this Anavex 2-73 that stopped the epileptic fits those Rett girls.”

Are there tort law considerations for the prescribing physician? Medical malpractice concerns? Institutional restrictions?

Or, could the drug simply be prescribed by many physicians, based upon very favorable anecdotal outcomes for non-indicated conditions?