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SC8

03/29/23 8:06 AM

#159184 RE: Big Al T #159180

Like I said, earliest IDE submission is likely months away. You're forecast is a bit rosier than mine, but we're both in agreement it is likely months off.

Regarding last RDGL update:
Can't say all pre-clinical testing is completed until IDE application is approved.
Can't say the planned "final draft" of the IDE application is indeed the final draft until FDA feedback is received and FDA suggests IDE application submission. A draft is just that, a draft submitted to FDA for review and comment under pre-submission program.
Even if FDA feedback on "final draft" is looks great, no meeting needed, go ahead and submit IDE application, we're still talking about months to IDE submission. But if 4th meeting needed..............................
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kennewickman1

03/29/23 2:30 PM

#159207 RE: Big Al T #159180

dont be ridiculous