Govt. jockeying this horse.
FYI, for those who think clinical trials .gov site is accurate, it's not, it's just a guide.
The 4430 Ph1 safety trial announced completed today (and was done in early March).
But TODAY it says:
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430
This study is currently recruiting participants.
I'm leaving the country name out of this zika story that came across the wire today...but put the U.S. as the country and displayed on major news outlets...what type of attention do you think BCRX garners?
Today, 11:45 AM
??? confirms four microcephaly cases tied to Zika
Four babies born with microcephaly linked to the Zika virus have been confirmed in ???, the health ministry said on Wednesday, out of 264 total cases of the mosquito-borne infection in the country.
Public health officials have been concerned about the possibility of a surge in the rare birth defect, seen in worrisome numbers in Brazil, as the virus spreads rapidly in Latin America and the Caribbean.
Fourteen pregnant women have contracted the virus, and six babies who were infected with Zika were born with malformations, including the microcephaly cases, the health ministry said.
The communication valve turned off last August when the PH1 trial finished the first cohort and the 2nd cohort put on pause.
Detailed data was released to EMA from BCRX with color slides provided and shown on the EMA report of the 1 cohort data. NOTHING provided to investors other than the 1st cohort was considered generally safe.
The PH1 trial was announced as completed today, why no projection provided in the last couple CCs this year? No one would have known this thing was completed (before today) outside of this MB in March. No bullet points from BCRX of anticipated completion date this year, however they provided this estimated guidance before on 4430 last year. Why not tell us it's coming to an end?
Stonehouse today said the PH1 was completed and more details to come...why not today? Come when?
Purposely Vague for what purpose and by whose authority?
Yep, and BCRX is moving forward with this program.
Study on zika infected animals to confirm safety in pregnancy.
Upcoming details on the PH1 data to be released at a later date, some type of antiviral conference likely. Regardless, BCRX and the govt. know the detailed results and that's why they are confidently moving forward with the IV study and further animal testing against zika.
thumbs down all you want, 4430 is the next major catalyst for BCRX. Release of funding will be a big deal for BCRX.
When the flood of money is released from Congress then all the talk about BCRX and Zika will come out and those taking positions over the last few months and trying desperately today will makes lots of money.
May 5: Florida governor to Congress: Must treat Zika virus like a hurricane
May 2: Buchanan Calls for Full Funding to Eradicate Zika
April 30: Pelosi: 900 Cases of Zika & Counting
May 3: "MURPHY CALLS FOR EMERGENCY FUNDING TO COMBAT ZIKA AS FLORIDA REACHES 100 CASES" ....,..(WHAT, FLORIDA...huge political swing state).
They want your shares mdaddy...better turn off the computer and tend to the fowls in the back...lots of clucking, maybe a sneaky varmint trying to steal their eggs.
Just sayin' short interest hasn't been this low for over a year..
Our thumbs down stalker guy knows it's true and prefers others not to know it too.
I agree husky, CDC will use positive data at the appropriate time to get the biggest bang for their buck.
Get funding first. A beggar doesn't tell you if he has $100 in his pocket.
Sellers today are shorts and uninformed retail...not the tutes.
or at least a kazoo.
Seriously, the PH1 safety data was completed in early March and now we're two months out being told about it.
Who else has a completed safety trial with multiple pathogens (including ZIKA, Ebola, Yellow Fever, Marburg) successfully tested against their BSA antiviral in various animal studies....NOBODY.
4430 can be approved with the animal rule. Another larger human safety study and we're done unless the FDA pulls an EUA.
Congress back in session on Monday!
A 22% drop in short interest and rise in PPS also hint towards good things to come.
4430 trial completed March 10th.
4161 hard tablet trial completing May 22nd.
Briefing on Zika by Dr. Anthony Fauci and Dr. Sylvain Aldighieri at PAHO on Tuesday, May 3 at 2:30 p.m.
Other news out today:
Zika virus: Risk higher than first thought, say doctors
By Wyre Davies
BBC News, Rio de Janeiro
2 hours ago
The mosquito-borne Zika virus may be even more dangerous than previously thought, scientists in Brazil say.
They told the BBC that Zika could be behind more damaging neurological conditions, affecting the babies of up to a fifth of infected pregnant women.
Zika Virus Birth Defects May Be 'Tip of the Iceberg', Experts Say
by MAGGIE FOX
The explosion of cases of birth defects caused by Zika virus may be the "tip of the iceberg," experts said Sunday.
Many cases have probably been missed because babies looked normal when they were born. But hidden birth defects are almost certain to turn up as the babies grow, they told a meeting of pediatricians Sunday in Baltimore.
"The microcephaly and other birth defects we have been seeing could be the tip of the iceberg," Dr. Sonja Rasmussen of the U.S. Centers for Disease Control and Prevention said at the annual meeting of the Pediatric Academic Societies.
"The true burden of congenital disease with Zika virus is probably underestimated," said Dr. Marco Safadi of the Santa Casa Medical School in Sao Paulo, Brazil, who's been treating and studying cases.
GUEST SPEAKERS: MEDICAL, BIOMEDICAL & BIODEFENSE: SUPPORT TO THE WARFIGHTER SYMPOSIUM
DAY 2: JUNE 8 (BIOMEDICAL, BIODEFENSE)
Panel – Biodefense Challenge to Warfighter, Veteran and Civilian: Emerging Infectious Diseases – A Global Challenge
Ray Taylor, Vice President, Corporate Planning, BioCryst Pharmaceuticals
If you got it you flaunt it..
BCRX did the mouse study in Feb., released data early March.
GILD has more capacity for testing and timing and we've heard nothin'.
When a major competitor says nothin', they're saying somethin'.
In their transcript from last night there's no discussion of positive testing with their antiviral towards zika or follow-up to their ebola efforts.
If 4430 is the better horse for a true BSA then it makes sense to bow out early (and buy the other horse).
Case management and treatment
Studies of A(H7N9) viruses isolated from humans suggest that they are resistant to adamantane antiviral agents but susceptible to neuraminidase inhibitors oseltamivir and zanamivir [19-21]. However, Arg292Lys substitutions in the viral neuraminidase associated with reduced susceptibility to neuraminidase inhibitors have been documented in several cases after the start of oseltamivir treatment . A study, describing a family cluster with probable human-to-human transmission, detected one amino acid substitution in the PB2 gene, two new mutations in the NA and six in the PB2 gene, which were not present in isolates from the first wave in 2013. These new isolates showed drug resistance to oseltamivir but were sensitive to peramivir
The two neuraminidase inhibitors available in the EU/EEA are: inhaled Z and T.
So a mutated H7N9 shows sensitivity to P but not T...reason enough for SNS anywhere.
ECDC PRELIMINARY SCIENTIFIC ADVICE
Expert Opinion on neuraminidase
inhibitors for prevention and treatment of
Stockholm, February 2016
There is a need for improved influenza antivirals, and a number are either authorised or in advanced clinical development:
Peramivir for intravenous use (novel neuraminidase inhibitor authorised in Japan and South Korea since 2009 and for uncomplicated influenza in the US since 2014)
...Even in parts of Asia, e.g. Japan, where use of antivirals has
134 been significantly greater than in the EU/EEA Member States, the level of antiviral resistance is low. The
135 neuraminidase inhibitors peramivir and laninamivir are licensed in some non EU/EEA countries; and peramivir is
136 also licensed for use in USA and Japan, and laninamivir in Japan.
Some countries in the EU/EEA follow a similar public health strategy as Japan to combine use of influenza
757 vaccination before the start of the influenza season, and use of influenza antivirals when needed in risk groups
758 including the large aging population. Currently, five neuraminidase inhibitors are approved for chemotherapy
759 against influenza in Japan where the highest frequency of use in the world is reported; favipiravir, laninamivir,
760 oseltamivir, peramivir, and zanamivir .
BCRX is making headway, who knows what's happened over the last 6 months:
PHE guidance on use of antiviral
agents for the treatment and
prophylaxis of seasonal influenza
Version 6.0, September 2015
Peramivir (IV) is a neuraminidase inhibitor which has been licensed in the United
States of America. It is available as an unlicensed drug in the UK, in a preparation for
Under the terms of the SUL Agreement, we received an upfront payment of $33.7 million, and we may receive up to $12.0 million in additional milestone payments related to the successful achievement of regulatory milestones, including marketing approval (i) by the FDA for a pediatric indication, (ii) by the EMA for an adult indication in the EU and (iii) by Health Canada for an adult indication in Canada.
Govt. of Canada:
Submissions Under Review
This is a list of new drug submissions (NDSs) that are currently being reviewed. These submissions are for drugs containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada. This applies to submissions whose review started on or after April 1, 2015.
Submissions Under Review List:
for systemic use
This upcoming earnings call may have some surprises with Peramivir via licensing $$$ if the company reached milestones unknown to us...filings in other countries, upgraded approvals in pediatrics, elderly, acute situations.
I don't have specific information but there's been more recent rumblings regarding P on the net.
Front Microbiol. 2016; 7: 450.
Published online 2016 Mar 31
Peramivir: A Novel Intravenous Neuraminidase Inhibitor for Treatment of Acute Influenza Infections
Successful clinical trials and post-marketing data in pediatric populations in Japan support the safety and efficacy of peramivir in this population where administration of other antivirals might not be feasible.
While currently only approved for treatment of uncomplicated influenza in adults, clinical studies and post-marketing efficacy and safety data in pediatric populations provide promise for the potential of approval of peramivir in this highly susceptible population.