But as I've said, an application for product approval is our top priority and laser-focused. We plan to file -- we have to get the commercial license first when I was just talking about. That is a prerequisite before being able to submit the application like the PIP, the pediatric investigation plan was a prerequisite. We had to get that done. So we have to have that. But our time line is to file as soon as we can. And we also plan to be strategic about filing in multiple places.
I share here my latest correspondence with Richard Parker, Senior GMDP Inspector - MHRA- London.
My Q.:
"Is the MIA approval a prerequisite for MAA submission?"
Reply from Richard Parker:
Dear XXXXX
The MIA process is separate to the MAA process so as long as the potential MIA applicant has a clear vision of the product they intend to manufacture then an application can be made prior to an MA application. They must be GMP inspection ready and be able to demonstrate the capability to manufacture the final product during the inspection.
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