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doccjc

06/23/22 2:56 PM

#147828 RE: WALLnut #147827

Constant reminders.
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SC8

06/23/22 3:19 PM

#147829 RE: WALLnut #147827

Again, please keep it real. Would be lucky if there are test results to submit to FDA in two months. It's not like once FDA gives green light on test plan that testing starts next day. Contracts have to be drawn referencing the approved test plan and JHU paid to commence tests. Then the select strain of animals and supplies have to be procured, etc. Then tests will take ~6 weeks. Then a couple weeks to write up report. Then submit to FDA and wait. Then another discussion meeting, etc. IDE submission in two months is highly unlikely. As far as old news, it's not old news that we are we still talking about upcoming re-tests when the product was changed last year. Anyone who knows anything about FDA approvals would know prior tests are worthless after such product changes. Yep, mistake of not commencing re-tests last year is water over the dam, but not old news cuz we're still dealing with it.