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Wednesday, September 30, 2015 11:50:14 AM
1.
So basically the German HE and British EA programs are now "LIKELY" dependent on the Phase III data??? Are you kidding dude? -- Austin
I'm not kidding, and I'm not your "dude," "buddy." (That last part was a call back joke) EAMS is dependent upon phase III data:
The EAMS scientific opinion can be issued based on Phase III data (in some exceptional cases also on Phase II data). The scheme will also involve a new National Institute for Health and Care Excellence (NICE) technology appraisal and NHS England commissioning process. This will allow for easier post-approval Health Technology Assessment (HTA) and pricing negotiations. -- http://www.pharmacompliancemonitor.com/early-access-medicines-scheme-eams/6836/
You can't price H.E. in Germany unless you know N.I.C.E. agrees as well. This is what Larry Smith meant when he stated pricing negotiations were more complex than he originally anticipated.
2.
So what is the exemption or HE good for, obviously if Phase III data is good the therapy would be approved anyway. So we would gain a few months in ramp up? I thought we were ramped up and ready to go already? -- Austin
The Hospital exemption allows access to therapy for Germans and Europeans. A.A. is in the U.S., which is on the other side of a large body of water called the Atlantic Ocean. It has different geopolitical boundaries. Great Britain and their EAMS program is also a fair distance from the United States. It too has different regulators. So you see, this is not simply buying NWBO a "few months."
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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