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loanranger

02/23/21 8:13 AM

#348339 RE: To infinity and beyond! #348320

"Or, is there a larger US trial? Obv it ought to show on clinical trials site- today, maybe?"

I've provided the rule but it's hard to say whether the Company will abide by it. Some don't.
The REQUIREMENT is to register the trial on the clinicaltrials.gov website within the 21 day period following the first patient's enrollment.


Link previously provided.
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JohnLocke101

02/23/21 8:23 AM

#348344 RE: To infinity and beyond! #348320

We don’t know all of the specifics of any trial. We do know the company had a pre-IND meeting with the fda where they (presumably) discussed clinical trial purpose, objectives, plan, design, etc.. and I assume the company isn’t ignoring the information they received and instead are following guidance given.

https://www.oraclinical.com/resource/the-basics-of-a-pre-ind-meeting/

Good Luck!