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biosectinvestor

11/01/21 4:24 PM

#414148 RE: hyperopia #414147

That is a hopeful schedule. Fairly fast despite the EMA/EU, which is horrible in terms of timing and bureaucracy.
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ccie1024

11/01/21 4:50 PM

#414158 RE: hyperopia #414147

Amgen’s timeline for Sotorasib...



An *approval before *publication...
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antihama

11/02/21 6:02 PM

#414428 RE: hyperopia #414147

Good stuff. And I would add the BTD PR to your list since it portends good news to come:

Dec. 8, 2020- Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
Sotorasib Also Accepted Into FDA's Real-Time Oncology Review Pilot Program
New Drug Application Submission to FDA Planned by End of the Year
https://www.amgen.com/newsroom/press-releases/2020/12/amgens-sotorasib-granted-breakthrough-therapy-designation-for-advanced-or-metastatic-nonsmall-cell-lung-cancer-patients-with-kras-g12c-mutation

So the order of things is
1) TLD (then)
2) BTD

3,4,5,6, etc) Everything else