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Re: mc73 post# 178698

Tuesday, 08/13/2024 1:25:28 AM

Tuesday, August 13, 2024 1:25:28 AM

Post# of 180558
IDE was not approved on time, FDA and CEO both side must take responsibilities.

CEO's mistakes:
1, didn't make clear to ask FDA: what kind of all requests FDA needed and with written notice, not oral,
2, CEO didn't employ a smart lawyer to protect company's interest, If FDA did some wrong, CEO can use lawyer to sue FDA.

FDA's mistakes: 1. FDA didn't work hard to finish the review application on time, 2, FDA didn't tell RDGL all of requests with written notice about IDE. So, 5-10 % of requests still left.

Suggest CEO: This time CEO must correct above two mistakes to protect company and share-holder's interests. Ask FDA all of left 10% request in written, and mean time engage a lawyer to protect RDGL shareholder's interests.
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