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MasterKit

09/19/23 1:52 PM

#632455 RE: skitahoe #632446

LP said herself that most of the documents (Master Trial Data) only needs to be inspection ready. They would not need to submit the data, only have it ready if a regulator needs to examine a part of it.

With the electronic submission options that MHRA and FDA uses, the actual uploading of data is really quite simple compared to how it was done in the past. To be clear: they are not uploading 1.7m pages anywhere.