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User-840664

01/28/24 12:35 PM

#668064 RE: sukus #668061

OK, first of all it's not getting approved..
Secondly, LP avoided Canada, FDA and EU for a reason...
Thirdly, she chose pink sheets to avoid transparency that comes with real exchanges' requirements ( hence all the secrecy)
Fourthly, even on a miraculous approval, NW gets only a small royalty from Advent, the LP owned Manufacturer!
Fifth, YOU ARE NOT THE REGULATOR, and for good reason!
Sixth, stop misleading people.
Seventh, NWBO will most likely not be an entity in 12 months

My opinions , of course
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exwannabe

01/28/24 12:36 PM

#668066 RE: sukus #668061

Sure.

They have a single trial where patients on SOC+L prior to progression did no better than those on SOC prior to progression. As measured both by the predefined primary endpoint of PFS but also by OS. That kind of creates doubt.

They changed to cross trial comps only years after knowing hat happened. The trial remained formally blinded to patient level data, but that does not mean they did not know the results of various analysis made using the unblinded data. We know as a fact that there was an efficacy IA i 2015, and anybody with a brain knows they were taking looks at the OS between the arms as the tail progressed hoping for the tail. And that makes the change post hoc.

The ECA they used was summary level data only which prevents it for being adjusted to patient level differences. Though there is some math that can be used, it is crude and the results have not even been disclosed.

The extend of resection issue is huge. The -L trial required intent for near total resection. ECA patients with near total resections lived as long as -L patients with near total resections.

95%? LMAO.
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attilathehunt

01/29/24 10:46 AM

#668382 RE: sukus #668061

stop giving them credibility by replying to their text. Just ignore them is the BEST course of action.