Another thing running behind time:
From announcement 21 June 2018
In China, SUDA’s licensee, Eddingpharm, anticipates submitting a Clinical Trial Application in the next few months.
This has required substantial work by the teams at both Eddingpharm and SUDA.
Eddingpharm is required to conduct a small pharmacokinetic study to demonstrate that ZolpiMist is bioequivalent to the Chinese branded tablet.
With the successful completion of this study, Eddingpharm will be in a position to submit its New Drug Application to the Chinese FDA.
No news on the Clinical Trial Application being submitted
Another thing running behind time: From announcement 21 June...
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