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Gsdubb

04/01/14 7:14 AM

#6658 RE: Dragon Lady #6654

They have to say"may" and similar words as until you have adequate safety an efficacy data you can't make any claims. This is clinical trials, FDA, 101 class.

Gsdubb

04/01/14 7:22 AM

#6659 RE: Dragon Lady #6654

I recall reading in the published Marvel results that patients in the placebo group experienced arrhythmia as well. Regardless of potential side effects, the FDA allowed the reduction of about 200 patients for the trial based on SAFETY statistical data of Myoblast transplantation. I'd say that's pretty good wouldn't you??

Gsdubb

04/01/14 7:38 AM

#6660 RE: Dragon Lady #6654

Wait a minute. That doesn't make sense. If the whole purpose of injecting cells into SCAR Tissue is to improve the function, how are you creating scars with the needle in something that is already a scar? It's already a scar. Unless they mean the potential risk of the needle touching healthy contractile muscle which should be a documented risk of user or device error in the company's risk documentation.