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H2theIzzo

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H2theIzzo

Re: None

Thursday, 06/22/2017 5:04:21 PM

Thursday, June 22, 2017 5:04:21 PM

Post# of 689037
Can someone layout an approximate timeline about what happens at the end of the the trial when the O/s events are reached. I'm a newbie to the FDA approval process but gather that after datalock there would have to be some analysis of the data and then some type of submission to FDA then a waiting approval. I'm sure this is basic to some but I have no idea what steps and time frame it takes to get from data lock to a decision by FDA. Thanks in advance.
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