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CatfishHunter

03/17/23 8:13 PM

#158783 RE: SC8 #158776

Read the update again. Better yet see below to make it easier. Company already commented the final draft will be the application submission.

“All the pre-clinical testing is completed, except for the VX-2/rabbit study, so we submitted a draft IDE. It is prudent to obtain continuous FDA feedback to expedite the final submittal. It is anticipated that the FDA comments will be received in early April. After the animal study is completed the final draft of the IDE will be submitted.”