Monday, January 02, 2023 2:23:05 PM
Not as simple as just print another set….
Here’s the transcript and thanks to Senti for the transcript:
So one of the portions of work that we've been working on has been getting the trial master file in shape. And we're working with the contract research organization, the CRO and the specialized consultants who are working with us on the application package.
And we have very strict procedures. No one from Northwest is able to touch anything. You remember that as we went through the clinical trial, all of the data was collected by the independent CRO and was held by an independent database party and was delivered directly to the independent statisticians who crunched the numbers [did the] survival curves, calculated the hazard ratios and all that and gave the results to us.
So all of these attacks that you're seeing about [indiscernible], we don't have the ability to do it. The data was never in our hands. [Similarly] with these documents with the trial master file. No one at Northwest has these we're involved in the process, we're overseeing, but we're scrupulous about all of it being only in the hands of the independent CRO and consultants.
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