SEOUL, Oct. 12 (Yonhap) -- The patient once thought to be the last South Korean with Middle East Respiratory Syndrome (MERS) has been rediagnosed with the viral disease, officials said Monday.
Oct. 9th A Scottish nurse who contracted Ebola in Sierra Leone last year is in a "serious condition" after being readmitted to an isolation unit in London.
NHS Greater Glasgow and Clyde confirmed that the virus is still present in Pauline Cafferkey's body after being left over from the original infection.
It's about the timing. arguably some shlock lawyer NOW could make a legal case that this was "hidden" and should have been disclosed earlier. How long has 4161 been in trials...long enough for this CARC test to be completed. How long have investors been betting on 4161...since PH1 data.
Jon inferred that the PPS could resemble DYAX with the positive release of 7353 data (back in March he said this) in a BofA Q&A. Well, here we are with positive data with a weight around its neck. Someone didn't want THIS timing for the PPS to go up...maybe later, not now.
No one has been a bigger believer in me in Jon & Co.
I don't question Jon's integrity but not looking at things from a linear paradigm.
This CARC issue has been known since the beginning, I can't get an answer why NOW BCRX releases this concern. This is a legitimate question to ask and expect an answer and none was provided.
If BCRX wanted to avoid the appearance of hiding something then this should have been discussed long before now. Instead, they drop this bomb on the release of POSITIVE 7353 data. Why would you do this if you weren't trying to quell the response?
Consider that this CARC test may have ZERO issues when the final 4161 data is released 1Q.
I'm sorry, but this stinks to high heaven. I don't doubt the future success of BCRX, BUT it's not right to be manipulated...and Jon might be the one who is being manipulated...that's my point.
Who's at the helm? Starting to wonder.
Not happy about the revealing of the CARC issues now, that could have been stated long before. On purpose fumble?
The BioCryst drug development programs
have required extensive funding over the years, but we have still
spent considerably less than the average cost involved in getting
drugs to market. Maybe that is attributable to the added efficiency
of structure-based design, but we will have to wait and see when
the BioCryst compounds now in development reach the market.
Above all else, it is clear to me that structure-based design allows
a small, focused team to undertake pharmaceutical design and
development projects that have generally been the sole purview
of large pharmaceutical companies.
BioCryst Licenses Worldwide Rights to Commercialize RAPIVAB(R) Influenza Treatment to CSL Limited
"With its expertise and global scale in influenza, bioCSL is the ideal partner to commercialize RAPIVAB in the U.S. and to work with us to pursue additional approvals in Europe, Canada and other rest of world markets. bioCSL has strong pandemic franchises and has successfully negotiated a number of significant government influenza product stockpiling contracts around the globe," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst.
October 8, 2015
A major new national report into the use of antiviral drugs (neuraminidase inhibitors) to treat and prevent influenza has drawn heavily on two pieces of research undertaken at The University of Nottingham.
The landmark report, published today by the Academy of Medical Sciences and the Wellcome Trust, concludes that anti-viral drugs called neuraminidase inhibitors (NAIs) were successful in reducing deaths in hospitalised patients. And that prophylactic use of the same drugs in households prevents flu infection.
It directly cites evidence from the Post-Pandemic Review of the anti-Influenza Drug Effectiveness (PRIDE), and a World Health Organization sponsored review of neuraminidase for rapid containment of influenza, both of which were led by Professor Jonathan Van Tam and his colleagues in the Health Protection and Influenza Research Group in the University's School of Medicine.
EU approval of IV P in the works.
Biotech...full of surprises!
Up next this Q.
4430 results with possible contracts and FDA approval path. Favorable outcome points to potential ~1 Bln stockpile.
Peramivir stockpiling...it's due!
CDC guidelines: "Limited data suggest that oseltamivir administered orally or by oro/naso gastric tube is well absorbed in critically ill influenza patients, including those in the intensive care unit, on continuous renal replacement therapy, and/or on extracorporeal membrane oxygenation."
"However, for patients who cannot tolerate or absorb oral or enterically-administered oseltamivir because of suspected or known gastric stasis, malabsorption, or gastrointestinal bleeding, the use of intravenous peramivir or investigational intravenous zanamivir should be considered."
If you have an IV option you wouldn't even consider an oro/naso gastic tube. Why jam a tube down a patient to deliver medicine if they have an IV port??? Especially based on "limited data suggests...".
YES, I do think this is about pricing, these recommendations are NOT based on science or common sense. With an IV the full dose of medicine goes straight to the blood, NO question about absorption.
Copper, I'm pretty confident CSL is working out lower pricing for the upcoming flu season.
I expect the $1000 price tag will go down now that CSL is in control. They want their drug USED not on a shelf.
CDC guidelines allow for IV P but at THIS TIME recommend oral T and even tube delivery. The govt. is using this as Price Pressure if you ask me. An IV is a more logical use as it is 1) given once for 5 day treatment not twice a day as T is 2) Dose adjustment for children, renally impaired 3) No question on absorbtion 4) Goes straight to blood and helps to keep virus from changing.
COST is the issue b/c P is similar in effectiveness to T.
I won't be surprised to see a price of $500. HHS stockpile at 20% of that cost (same as T).
As the price comes down (and that may have already been agreed upon) I expect to see CDC guidelines change more favorably to an IV and the HHS stockpile to follow...all coming this quarter.
Ebola Therapeutics Development. Additionally, the U.S. government is supporting the development of investigational therapeutics to treat patients infected with Ebola.
...BCX4430: BCX4430 is a small molecule drug developed by BioCryst Pharmaceuticals with support from NIH and currently is undergoing advanced development with support from BARDA. NIH-sponsored Phase 1 clinical studies in healthy volunteers began in December 2014 to determine safety and a treatment dosage. In July, BARDA began supporting advanced development of the drug, including improving manufacturing processes and scale up production of the drug in U.S. facilities to increase product yield, reduce process steps, and increase scalability of manufacturing so that thousands of doses can be made with consistent product quality.
FDA continues to work with product sponsors, U.S. government funding agencies, and international partners, to clarify data, clinical studies, and regulatory requirements necessary to facilitate the development and expedite the availability of the most promising vaccines and therapeutics that could potentially mitigate the current Ebola outbreak, as well as potential future outbreaks.
(they mention Zmapp and Mammalian cell monoclonal antibody therapeutic: BARDA is supporting the development of several mammalian cell-derived Ebola monoclonal antibody candidates from Regeneron and Genentech.)
Word correction: Concurrently, not Consecutively.
From CITI slide #3:
"2nd generation kallikrein inhibitor BCX7353 Phase 1
trial nearing completion—results in 4Q15"
Before they added the 14 day add-on to the PH1, BCRX was scheduled to have PH1 results this month.
So, we KNOW the first part of the PH1 has completed (7 days), and can assume the 14 day is / has been moving forward.
What does this mean?
During the Aug. 7th CC BCRX was asked if the 7 day and 14 day would run consecutively. Stonehouse said NO, they will first look at the 7 day data.
That means, they were satisfied with what they saw in the 7 days results to continue on with the 14 day extension.
Smarter people can extrapolate what this means, but I think DYAX is nervous AND we are likely to hear results in Oct. as the trial was a "modest" delay for results.
FYI, BCRX just hired a PATENT Lawyer (new position) for all their new kallekrein inhibitor molecules. Also, don't forget the big move they're making in Birmingham into the new research center that they're building right now.
Yeah, BCRX is bullish about their future.