Forbes: Aug. 29, 2014
BioCryst to Launch NHP Ebola Drug Safety Studies 'Within Weeks'
"Their goal is to develop the drug under FDA’s Animal Rule that permits non-human primate efficacy and safety studies for conditional approval as phase I human trials proceed."
I know that you're not a sharp fella, but I had no clue you were this dense in the head. Anything and everything you say on here is fueled by jealously and hatred towards maphere. You've mocked him for months and months re: 4430 yet 4430 was what pushed us through long, intermediate, and short term resistance. Until that point we were already up in the 12's and 13's coming off of the amazing HAE data and strong secondary offering. We're in the 13's now, so we haven't really done much since that Ebola interest came in. Contrast this with 2009 when we went from 4 to 13 all on the H1N1 pandemic.
Also, I suggest you take another look at the updated insider holders of this company: investing.money.msn.c*m/investments/institutional-ownership?symbol=BCRX. See those Baker guys at the top with over 10M shares? That's their top 7-8 largest position by value and 6-7 by shares. You think these guys were pouring in their money into this when they scooped up another 5M shares at the latest secondary at 10 for a future Ebola outbreak? No, they were buying the HAE data.
You're nuts if you think anyone on this board thinks you're any more credible than an ant on the ground at this point. You were screaming sell on the last pullback to 7 calling for a 4 and lower PT all while spamming the board with a $1 StockCharts price target. StockCharts isn't very relevant, but it does now say $22 for the price target after the quad top breakout. I noticed you're not posting that anymore on here though. Interesting.
The bottom line here is that you were wrong and now you're wishing and hoping and praying that the stock pulls back so you can tell maphere that he was wrong and you can get back in the stock because you know the potential here.
You're a joke Cabo and a sad human being. The end.
Fact: The US FDA has never in their history ever rejected an NDA or PMA that was first approved in Japan. The reason being is Japan has the highest level of scrutiny outside the US for all applications, the reason why many companies choose Japan now a days is because 1. it's cheaper 2. much quicker response time 3. the World believes Japan has higher quality standards., since 1982, no application within the US filed by a US company first approved in Japan has ever been rejected. Not one! So, with those stats what do you think the chances are that BCRX's PDUFA is approved?
In my book it's almost a non issue.
Sentiment: Strong Buy
1. GSK is trying to develop it's own form of Peramivir but buying Peramivir would get them the stock pile business and eliminate competition for their own offering just starting phase III.
2. GSK would love to have 4430. Then they could boast of the vaccine and the cure.
3. 5208 would spice up the profit margin for their allopurinol offerings.
1 + 1 + 1 = 1.5 billion
BCRX keeps 4161
Wonder if CDC knows more than Nature? On the CDC website that NIH and BCRX are performing a trial THIS YEAR. A contract from NIH for 4 mln and purpose will soon hit the PR headlines. Push SEND Rob.
BioCryst submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S.A.
According to the company, Peramivir may address unmet needs in the treatment of influenza.
Since the drug has been given Fast Track Status, it is expected that it will be approved by the FDA by August 20, 2014
Source: Pelagia Research Library
New chemical entities of future for infectious diseases
Exactly what insider selling are you referring to? Last I checked there has not been any and the tutes have not been selling.
has always posted verifiable facts. On very rare occasions... an opinion.
I would miss his input on this MB. The problem is being attacked by individuals that would be picking up their teeth if they talked to me like that in person.
Maphere is a source of information... in a world of dis-information. He contributes his research freely. More than I can say for childish ranting.
Many of the longs here are enjoying watching our little company produce positive drugs for mankind. We lend them our money to give them the resources to pursue these panaceas'. Either you believe or don't. Just like trying to make something better...your crops...your family...your life...you gots to work at it.
O: Briefing documents released by the World Health Organization (WHO) regarding the use of available therapies for the treatment of the Ebola virus suggest that BCX4430 is unlikely to be utilized as a treatment in the current Ebola outbreak.
R: This is a lie, or at least a gross misinterpretation.
O: Specifically, the WHO wants to see evidence of efficacy in non-human primates as well as safety in a human study, neither of which BCX4430 possess.
R: This is true for now (and true for other drugs), but it says in the same WHO document: NHP studies in progress. No human safety data available yet. Phase 1 studies planned late 2014
O: Moreover, there is no supply of BCX4430 readily available.
R: This is a LIE: On the very same WHO document it says under "Number of doses available" = Adequate for phase 1 study plus ~40 treatment courses. 2000 courses potentially available in the second quarter of 2015.
O: While BCRX has not been promoting BCX4430 as a near-term Ebola treatment, we attribute recent strength in the stock to Ebola-related headlines which have attracted the interest of investors.
R: Subjective. The strength of the stock can also be attributed to anticipation of HAE PH2b and Rapivab approval.
If funded by mid‐Sept 2014, additional drug supply sufficient to finish a field study and
provide for 2,000 patient treatment courses could be available beginning in March
NIAID exercises option under agreement with BioCryst
BioCryst Pharmaceuticals disclosed that on June 17 the company and the National Institute of Allergy and Infectious Diseases, or NIAID, amended their agreement dated September 12, 2013 for the development of BCX4430. NIAID exercised Option 6 under the agreement to conduct drug product development activities relating to the development of an IV formulation of BCX4430, including preformulation and stability studies and the manufacture of non-GMP drug substance. Pursuant to the option, NIAID released an additional $1.89M to the company and all other terms and conditions of the agreement remain unchanged, BioCryst said.
GTFOH you child. Your record is ATROCIOUS. A legend in your own mind. Map has had it right about 4430 all along. It got us punched through that long term 13 level. Many here sold shares from the 1's to the 14's. You were screaming sell at 7 and a PT of 4. Haha. Just like your infamous BOTA call that went from 7 to sub 3. Your HALO call has done nada as well. On the other hand, BCRX has exploded. Who cares about the reason - price is what matters. And in the price game, maphere, husky, other longs here, OWN YOU.
You're terrible at this.
U Tube video
Get all your questions answered on Peramivir / Rapivab
Published on Sep 6, 2014
An analysis of phase 2 and phase 3 clinical trials shows that a single injected dose of the neuraminidase inhibitor (NAI) paramivir is safe and effective at alleviating influenza symptoms including fever and viral shedding when administered within 48 hours of the onset of symptoms. Researchers will present data on what may be the first new influenza drug in over a decade.
Bill Sheridan, BioCryst
Rich Whitley, University of Alabama at Birmingham
This is not a popularity contest and requires four slides and 5 minutes to get the message out.
First slide states that it is a broad spectrum anti viral that takes care of everything that plagues Africa and lists everything from yellow fever to Ebola.
Second slide states that it will deal with all Ebola strains from yesteryear, the one today, and those to come because of the way it works.
Third slide explaining how easy it is to make, store and administer.
The forth gives the web site address and a phone number. Tells them the stock trades on NASD and in Frankfurt, and tells them to have a nice day.
Received 9 May 2014; received in revised form 26 June 2014; accepted 8 July 2014. published online 13 August 2014.
Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir (I): A drug use investigation
Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010.
We conducted a drug use investigation of peramivir from October 2010 to February 2012 and evaluated its safety and effectiveness under routine clinical settings.
We collected data of 1309 patients from 189 facilities across Japan and examined safety in 1174 patients and effectiveness in 1158 patients. In total, 143 adverse events were observed with an incidence rate of 7.33% (86/1174).
Of these, 78 events were adverse drug reactions (ADRs) with an incidence rate of 4.34% (51/1174). The most frequently reported ADRs were diarrhea, vomiting, and nausea, with incidence rates of 1.87% (22/1174), 0.85% (10/1174), and 0.68% (8/1174), respectively.
Moreover, no ADR was reported as serious. ADR onset was within 3 days after the start of peramivir administration in 91.0% (71 events) of the 78 ADRs, and ADRs were resolved or improved within 7 days after onset in 96.2% (75 events) of the 78 ADRs. Neither patient characteristics nor treatment factors appeared to significantly affect drug safety.
With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. The present study demonstrates the safety and effectiveness of peramivir under routine clinical settings.
I've never liked the taste of jack
everyone tells him to just go back
either back to the days of happy hemmer riding again
or back to the pit of his dark dark den
love him or hate him I don't care
I've ridden this stock when others wouldn't dare
bought some in December and more the next June
In a year I can't remember and then it quickly ballooned
I came for Peramivir and I'm staying for HAE
For a few billion I'll be set free
Think they're tightening the screws on Stoney?
HAE is the driver and pivotal study could have it approved EOY15.
Rapivab coming this year.
4430 accelerated 6 months and if it shows safety / efficacy then big $$$ for stockpiling.
Is it possible, yes it is.
Time to rid the group of this pesky mosquito that keeps buzzing snide remarks in everyone's ear! Someone bring the Prep H and let us rid ourselves of the Hemorrhoid that is hemmer!
Sentiment: Strong Buy
July 29, 2014
Good article...nothing new to us as investors but as I said, more attention coming towards BCRX b/c of the EBOLA outbreak and great pre-clinical results of 4430.