HT-100,SMT C 1100!!!!!!!!!!!!!!!!

Any updates on HT-100 which is on hold now and also SMT C 1100?

 

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Permalink Reply by Aleksandar on April 24, 2014 at 10:51am

Halo is hoping to be able to send all the necessary information to FDA by end of this Month, and hopefully get response to restart the dosing by end of May.

Permalink Reply by Moein on April 24, 2014 at 12:19pm

Thank you Alexandar.Does this mean that the result for Halo is positive and the toxic reaction was specific to dogs?

Permalink Reply by Aleksandar on April 24, 2014 at 12:31pm

I do not have that information, but based on their FAQ it sounds that it could very well be. Keep in mind that Dogs had toxic reaction after they kept increasing the doses. Doses that were given to children were safe.

Permalink Reply by David on April 24, 2014 at 9:39pm
I have info from reliable source from February 2014 that the sponsors viewed the FDA hold as a routine matter ... restarting this summer seems plausible to me. I'm in Sacramento where the trial is located so following it closely

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