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Re: The ELTP King post# 374699

Tuesday, 10/18/2022 4:58:42 PM

Tuesday, October 18, 2022 4:58:42 PM

Post# of 402260
You can decide to trust input from an anonymous user posts over fda websites, or you can read and interpret actual FDA documentation. I made it easy by posting a link below. From my read of it the process is not substantial, costly, or time-consuming'. It does mention the possibility of needing to submit a form as much as 2 months prior though (not very much of a delay given they plan to start marketing in Mar).

In my opinion it makes zero sense for a company to have to repeat costly tests just because they chose not to market a drug. Between the FDA documentation and common sense I choose to conclude that WeeZuhl is mistaken in his opinion.

See page 7, question 10 in the document below. It only mentions submitted notifcation forms no costly testing.
From https://www.fda.gov/media/138389/download
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