FLU-V NIH8 Nov 2018 06:58
The way I see it goes back to the RNS of March 26th this year....
"Kym Denny, CEO of hVIVO, commented:Â
"While we note the preliminary determination that the primary endpoint only trended to statistical significance, we are mindful of the prespecified additional analysis being conducted by the NIH, that may have an impact, before opining conclusively. That said, the symptom reduction data we have seen in this study with FLU-v is incredibly exciting and consistent with this universal flu vaccine candidate's putative mechanism of action. In the real world, ultimately, it is symptom reduction that is a clinically meaningful outcome if it can reduce the more severe flu disease, which is the concern and significant burden of healthcare systems across the world. This is, to our knowledge, the first time a universal flu vaccine candidate has demonstrated statistically significant reduction in a symptom score in humans. As a result, we believe FLU-v could be the most advanced universal flu vaccine candidate in development. With its potential for significant disease efficacy, broad protection against all flu strains, simplified manufacturing and the ability to be administered as a stand-alone vaccine - rather than in combination with traditional seasonal flu vaccine - FLU-v could help provide relief from flu to people across the globe."
In particular - "we are mindful of the prespecified additional analysis being conducted by the NIH, that may have an impact, before opining conclusively."
We are still awaiting NIH conformation and as our trial was conducted by ourselves with our own vaccine any potential investor would surely want an independent verification before singing a deal. Hvivo isn't in control of when this confirmation will land. It could be (and wouldn't it be nice) that a deal has already been lined up if the NIH results confirm our own. The results could land tomorrow or it could be weeks/months away but my guess is that there won't be any progress with Flu-v until this confirmation lands.
All in my opinion of course and don't mind being corrected if I'm way off the mark. DYOR