I don't have doubts about Biotem's ability to produce kits.
i don't have doubts about RHY's ability to reproduce the analyses on those kits.
I do have doubts about the Supply Chain responsible for the cartage of those kits from Biotem to RHY.
RHY share this sentiment and it is the reason as stated in the update why they chose to withdraw the application.
To proceed with the initial submission would be one giant bet that the kits leave Biotem and arrive at RHY without delay or issue. With a ticking clock that's an unacceptable level of risk.
Ann: Update to TGA Submission, page-196
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