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Re: frrol post# 112787

Wednesday, 07/26/2017 9:05:06 AM

Wednesday, July 26, 2017 9:05:06 AM

Post# of 471596
I'm really not familiar with the Phase 2/3 combo design as I've never researched it thoroughly.

From memory if I recall correctly Anavex already knows: 14 mg is the minimum effective dose, they know 50 mg is the maximum tolerated dose, they even said (again from memory) that 30 mg is the optimal dose.

If (I said if) I have that part correct, what's left to figure out? Which patients it will work best on I assume. (Ariana's task?)

If this guys comment is correct (he looks qualified to me)

https://www.tipranks.com/analysts/eric-schmidt



"A final-stage trial in Alzheimer’s disease can cost north of $200 million,
according to Eric Schmidt, an analyst with Cowen & Co. "

Ain't no way Anavex is probably gonna be able to generate that much cash out of an LPC type financing tool. Even if the combo 2/3 cut the cost in half. Raising $100 million through an ELOC would get ugly real fast.

So why try and do a combo 2/3 that would probably have to start with more patients than a regular 2b. Why not run a regular (properly designed for efficacy this time ) Phase 2b. You need a partner at the interim phase 2/3 analysis or you need a partner at the end of 2b (heck set up an interim look).

Did you catch that it costs $15,000 to $20,000 just to screen patients for Alzheimer's trials if I remember my last source correctly.

I don't get the 2/3 strategy other than including the words Phase 3 will get investors excited.

https://www.jstor.org/stable/27590571?seq=1#page_scan_tab_contents

http://www.cytel.com/blog/seamless-trials-now-that-we-get-the-statistics-whats-really-at-stake-
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