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Re: HappyLibrarian post# 236906

Friday, 07/19/2019 7:25:10 AM

Friday, July 19, 2019 7:25:10 AM

Post# of 700535
Sorry, but I do not quite understand your post. LP is alleged to have at least inferred they have a home run. LG has also allegedly said that they will continue to collect data until the results are undeniable. This could easily be interpreted to mean "undeniable for good or bad ".

However, I believe that NWBO needs very strong results especially if it fails to achieve primary/secondary endpoints. These will not go away even with an amended SAP. Home runs in OS milestones and remarkable efficacy in MES, which is the most aggressive cancer with the poorest survival and constitutes a relatively large sub-group, would go a long way to assure approval even though results for M- might be less than remarkable but still show some improved efficacy over SOC. The "home runs" may mitigate failure or unremarkable results in the primary/secondary endpoints leading to approval.

I do not know whether NWBO, in fact and absent unblinding, has any home run. LP does not know for sure either unless somehow she knows what the unblinded results are. I believe that is highly unlikely. However, given her expert statisticians, the SAB, PIs and the data NWBO already has, I believe she has a good indication of how the trial will play out. JMHO.
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