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Post# of 252311
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Alias Born 01/22/2006

Re: iwfal post# 205047

Saturday, 10/08/2016 1:01:58 PM

Saturday, October 08, 2016 1:01:58 PM

Post# of 252311
AUPH:

I sold out at AUPH at a loss so my thoughts may not be worth much... The things that got me selling (originally before results and then the remaining for a loss shortly after):
1-The company claims its dose is not weight based and has lower tox because of a better pK. Looking at some older trials in other indications it appears that as the dose goes up the tox is more in line with other Calcineurin inhibitors. They broke out the results by male/female and interestingly men did better on higher dose and women on lower dose. I wonder if they did a weight based analysis and if part of the reason less deaths occurred in the higher dose was due to dose tapers or just overall lower compliance.
2-I was fairly sure FDA would require at least one (and likely 2) much longer trials (perhaps even 2 years as other lupus trials tended to be in that range)

While I am not certain obviously and the company did a good job at breaking down the deaths by site, I think there is something there also the costs to get to registration if my thinking is correct will be quite a lot of dilution lacking a partner (and diluting their ownership interest).

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