Anavex Life Sciences Corp (AVXL)

[boi568]

I think we are in agreement. My post indicated that Rett will come first.

The latest clue that Missling is willing to prioritize a cross-platform NDA over platform specific NDAs is in the details of the latest foundation grant, for imaging studies in PD.

Here is what Doc328 suggested before the details were known:

"I would guess that an imaging study for PD would compare baseline DAT-SPECT scans to repeat scans after a period of time (say 12 months) in placebo and A273 treated patients. We know that the specific binding ratio of the dopamine transporter (DAT) radiotracer in the striatum (globus pallidus and putamen) declines over time so that preventing this decline could be relevant and one day serve as a treatment effect biomarker.

A PET study is also possible but DAT-SPET scans are likely more sensitive to change over time."

A dopamine-related study is PD-specific and, I would assume, determinative regarding disease progression. But this is what we got instead:

"The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson’s disease."

The imaging is intended to document the MOA in people with Parkinson's. This is probably less useful in getting a PD-specific drug approval than it is in helping to get a CNS-level drug approval. In other words, Missling is going to sacrifice showing how 2-73 alleviates Parkinson dopamine issues in favor of showing how 2-73 acts upstream in the CNS. This only makes sense if he is ultimately aiming higher than one indication at a time.

I have my areas of strengths and weaknesses. NDA procedures and medical concerns are not my strengths. But my sense, nonetheless, is that a broad-based NDA, drawing support from numerous indications, just might be years quicker to approval than attacking indications seriatim.