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Re: HyGro post# 511282

Monday, 09/05/2022 7:05:53 PM

Monday, September 05, 2022 7:05:53 PM

Post# of 701137
The pediatric trial approval is full approval and immediately actionable. There is no requirement for adult commercial approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.
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