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Re: robi-1-kenobi post# 82065

Friday, 02/21/2014 7:58:14 AM

Friday, February 21, 2014 7:58:14 AM

Post# of 146240
Thanks. Interesting posts. So maybe science related fears aren't the reason for delay. But consider....

THe company pr's about tox studies were very clear about the most recent targeted completion date of June, 2013 plus or minus 3 months. I understand your statement:

..this early range-finding Tox study is standard practice in industry to avoid wasting money finding your maximum dose in the more expensive, GLP constrained, IND-enabling Tox Study.



My problem is that they were not talking about this "pre-tox" when they gave us the June, 2013 target date. Somehow, we got range-finding tox instead and now we are going to end up with yet another year of delay.

Admittedly, I am simply speculating when I say there must be some sort of issue with the cides. To me, the only other reason for a delay this long is lack of motivation to move forward.

We went through the same kinds of extended delay working up to the pre-IND meeting. Was that really in 2011? They had talked about the pre-IND meeting for years as well. Has there really been that little progress toward trials in 3 years?


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