As said before, Carestart was granted two ( from memory ) FDA addendums to its approval. The first was for extension of shelf life, the second for something else ( I forget ).
If AT1 bundled this data in with the application it may take up extra time.
Appealing to the TGA may not be wise, but newspapers are ready to listen.
The Guardian already reported the Pantonic Carestart approved, Carestart Atomo deafining silence situation. Today I wrote to Theage about it. Why not? they are inviting people to tell their RAT stories on their website. Fire away.
AT1 FY21 - General Discussion + FA, page-1915
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