how many times have u seen a company stop and start a new trial in phase 3 ? with the reason being , wanting to make the procedure more minimally invasive ? stopping a trial to have a shorter trial is basically , a shortcut. we will have a better product , and will reach approval in a shorter period of time.
do you reckon the company can stop a trial and think of having a new strategy , without having the blessings of the fda ??
if the fda had any problems they wouldnt have agreed to the stopping of the trials.
they need to agree on protocols and endpoints , but believe me , the fda are helping the company reach a positive outcome.
reason ? better product and large market and our product ( with current modifications ) has less of a risk profile in comparison to lvads.
still a long way. but still a buy . always was.
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interesting upgrade, page-18
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