Anyone here aware of IV Zanamivir studies reported by NBSB in 2009.....
and all of the bruhaha and lack of substantiated endpoints that surrounded running hospitalized flu patient studies; and the fact that GSK finally gave up in exasperation? Because if you did, then hanging your hopes on Biocryst with the phase 3 Peramivir hospital study was a pipe dream, n'est ce pas?
Look at the posts under "ISIRV: Peramivir: Oct. 11, 2013" by map and husky. GSK gave up their pursuit of a trial for hospitalized flu patients with IV Zanamivir in 2009. How the h... was Biocryst talked into doing this? And if this info was available back then, why have so many on this board invested any credence in the Biocryst trial, which as we now see predictably ended up as futile?
FDA received a lot of backlash over the true effectiveness of Tamiflu, it was in their best interest to force P to at least be tried with patients not receiving SOC. It proved futile just like GSK expected back in 09.
FDA can at least say "they tried" and now the approval can come and IV P will be used for both seasonal and off-label for hospitalized / Urgent Care / and Long Term Care facilities in the US and ROW based on existing trials and scientific publications, same as tamiflu.
Because we know an IV antiviral is desperately needed in the US and the world.
Because the EUA was granted in 2009 and 2,250 courses were purchased for $20M+ by the USG for an unapproved drug. The EUA was the first of its kind.
Because we know peramivir works (Japan studies, EUA). We know it's safe (Phase III trials in US). We've seen study after study demonstrating its effectiveness compared to Tamiflu. The infectious disease doctors are begging for it and warned the USG years ago that their trials and endpoints were flawed and would not yield statistically significant results.
Because it's been approved in Japan, South Korea, and China (albeit their knock off version, no surprise there).
Because it brings momentum and trading opportunities to the stock whenever the inevitable flu kicks up and causes concern and panic.
Because the USG invested $230M+ into the trials.
Because BCRX doesn't need to sell a lot of it to make money since their number of outstanding shares is low.
For a big company like GSK, the return is not worth the effort. For a small company like BCRX, it is.