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Re: hyperopia post# 300438

Sunday, 08/16/2020 9:56:51 PM

Sunday, August 16, 2020 9:56:51 PM

Post# of 724419
I hope you are right!

It seemed to me that the company had a SAP that simply needed finalizing in the fall of 2018, but may have gotten wind of (or had something to do with) the new FDA Guidance that came out last year and then apparently decided to completely rewrite the SAP.
I suspect that Dr. Duffy was heavily involved in that process.
So the Direct trials were put on hold to redesign and update the protocols and endpoints, and while this appears to be a backstep, it may actually end up being many steps forward in the long run.


That is why I find this tidbit in the 10Q somewhat encouraging in regards to Direct: that the trial design activities and preparations with the trial sites continue.
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