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Re: biotech2010 post# 2056

Tuesday, 08/11/2015 11:37:57 AM

Tuesday, August 11, 2015 11:37:57 AM

Post# of 3833
I don't think it would "delay the study" because of having to change the "trial protocol" filed "with the FDA". I say that because CT*X has been adding new clinical sites to its trials after the trials began. (And the stated purpose was to accelerate the trial to completion.) As to adding additional researchers; even if they will need more researchers, they still have over two years left on the trial. I think they have time to hire additional staff if necessary.

At the projected enrollment rate with only one site, they will only average a little over one patient per week. Since patients who are waiting on this treatment are dying every day; that two and a half year timeline seems almost criminal. I hope they speed things up...

As for increasing the number of CX sites, that won't happen for several reasons, one of which is they would need to add additional researchers and it is too late to do that, it's also very possible that once they have filed the trial protocol with the FDA any changes would delay the study. But ask Traber that question on the blog, it would be a good way to test the process.
- biotech2010

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