On Feb 29, at the last CC, Stan said, 'a month or two' for a more detailed Flu update...
Looks like early May 4th it is for the Flu update at the 1Q Earnings CC. Perhaps a PR morning of...
Hoping for yield increase as BioPro alluded to after the last CC on Feb 29, along with perhaps more discussion on the NVAX NA / nueraminidase advantage that is now published and supported by independent scientific research. Hopefully more on BARDA and the H7N9 pandemic program too. (BioPro suggested that the programs are tied together.) At least another mention of the RSV/Flu combo and the Matrix-M possibilities.
Also... If we are getting a meaningful Flu update, it would be nice for NVAX to emphasize how egg-based vaccines have been basically worthless against the H3N2 flu that we experienced in 2014/2015. That's another huge advantage for NVAX's Flu Platform.
Also... Hopefully a significant Zika update after being mentioned in the WHO publication and the big Zika Summit in Paris last week. Zika is a huge wildcard.
I doubt we will get any new info on an overseas partner but you never know.
FOTD... Too bad you're an ER doctor, you would have made a brilliant biotech analyst!
What do these guys at Gug know that geniuses like filvax, jwilbanks, quabra & crushshorts don't?
The same things that BARDA, BMGF, 77% Tutes, FOTD, Lobster, Bball and the rest of us longs know...
Q1 CC on May 4th... Quad flu & Zika updates expected...
Q3 Ph3 RSV Resolve data in August or September.
FOTD, (Friend of the Devil), is from The Grateful Dead's, ' America Beauty' album.
"Set out runnin' but I take my time,
A friend of the devil is a friend of mine,
If I get home before daylight, I just might get some sleep tonight."
FOTD is an ER doctor from California and is undoubtedly familiar with the Grateful Dead and working many many late nights in the ER, hence his ID.
FOTD has also been investing in biotech for decades and really knows what he is talking about. He even profited greatly as an investor in Lobster & Fries old company, ID Biomedical as it was acquired by GSK.
FOTD is a great asset to this or any biotech message board. ER docs are not only brilliant but they how to key-in on critical details ASAP.
International Zika Summitt in Paris right now...
I'll double down on Glenn being there.... How could he not be there?
Consider: The WHO & BMGF are two of the big sponsors of this Summit. The WHO just listed NVAX as one of the companies working on a Zika vaccine. Glenn was the one to first bring up Zika vaccine work by NVAX... And the BMGF has yet to really open their pockets for Zika funding.
Good things are brewing for NVAX while we eagerly await Q3 Ph3 Resolve data and Flu updates.
I'll bet Glenn is in Paris for the newly announced Zika meeting sponsored by Institute Pasteur & BMGF:
'Disease experts to compare Zika notes in Paris'
Mariëtte Le Roux. AFP
April 24, 2016
Excerpt: "Scientists and public health specialists meeting in Paris will review progress in the development of Zika diagnostics and vaccines.
Some 600 disease experts from 43 nations will gather in Paris on Monday to pour over scant but increasingly worrisome data emerging about the Zika virus sweeping Latin America and threatening the world.
Scientists and public health specialists will discuss the virus' links to microcephaly, a disorder that causes severe brain damage in babies, and to adult-onset neurological problems such as Guillain-Barre Syndrome, which can cause paralysis and death.
They will also review progress in the development of Zika diagnostics and vaccines, according to the Institut Pasteur, which will host the science meeting over Monday and Tuesday.
"It is now clear that the Zika virus can cause serious complications, and the World Health Organization (WHO) declared the current outbreak a public health emergency of international concern," Institut Pasteur president Christian Brechot told AFP by email.
"It is therefore urgent to bring together key global players in research and health."
Mass, annual Zika vaccinations now seem like a reality. The company(s), selling these vaccine(s), will make billions annually...
One thing that struck me about Glenn's Zika comments at the Feb 29, CC, was his mention of mass production. Why mention mass production unless you have very high confidence in NVAX's ability to deliver?
As a reminder, when the WHO publication of the Ebola Vaccine Landscape came out, we were equally as thrilled to see NVAX in the mix. Then, when we all expected Glenn to show up at local Ebola conference in Maryland, it turned out that Glenn was sitting at the table with th WHO in Geneva on a much higher lever of Ebola discussions...
FWIW, Geneva has a 6 hour time difference from NVAX HQ...
As I said months ago, Zika will explode during the August Summer Olympics. World travelers will visit the epicenter of Zika, get bit by stealth mosquitoes, then return home where local mosquitoes will bite them and pass the Zika virus around.
Again... It's not just fetuses that are at risk, it's everyone. The Zika virus causes terrifying neurological damage in all age groups and its next to impossible to go through life without getting bit by mosquitoes.
It's seems clear that the Zika virus has mutated since its been less than 6 months before it started scaring the heck out of scientists, Lobster included.
People around the world will line up annually for their Zika vaccines... It could be the largest selling vaccine in the history of vaccines, topping even NVAX's RSV vaccine, and even the RSV/Flu combo.
I'm not a scientist but agree with Wily and others that having the E protein as a target sound very promising for NVAX in the same way NVAX targets the F protein for RSV.
And then we have the secret sauce, NVAX's, Matrix-M...Other companies will want to use Matrix-M too.
Q1 CC in a couple of weeks... Zika update, Flu update & more.
Back to Double Digits soon...
X-mon, Thanks for calling Dr, Glenn to get more color on Zika...
- I doubt she meant from Chicago, if she did AZN, London.
If she meant NVAX, Maryland, here are the likely suspects...
- Sanofi, France is 6 hours. Sanofi is leading the Zika vaccine race and has been working with NVAX's Matrix-M in their flu vaccines. Sanofi could be thinking of adding Matrix-M to their Zika vaccine (&/or, buying NVAX).
- As Wily pointed out, Novavax AB, home of Matrix-M, in Sweden is 6 hours away.
- The WHO, Switzerland is also 6 hours. With Zika rising, meetings are on the rise too. Glenn surprised us last year by attending a WHO meeting for Ebola.
- South Africa... also 6 hours. Glenn is at a conference sponsored by the BMGF in May.
- Truly Unfathomable News... A Family vacation...
Ayee: "already told my close family to buy this thing yesterday. Hard to sleep. So excited to see what today will bring. Unfathomable"
Sounds like B_S Think about it... What could be "Unfathomable" ?
FOTD, Thanks for sharing your considerable insights in biotech investing.
I know you're an ER doctor with 30 years investing experience in biotech and that you were an investor in Lobster & Fries, IDB through the buyout by GSK. Your posts carry a lot of weight and are invaluable, much like Lobsters.
Your take on the options & dilutions make complete sense. I feel the frustration that Clarkjohn and others feel with the 75% drop but remind myself, it's only a loss if you sell too early. (Which I have done more than a few time ;)
If biotech investing was easy, everyone would be doing it... It's not of course but the rewards are like nothing else when it all works out.
See you at $25+
From the FBR website:
Please join us at 12:30 p.m. for lunch with Dr. Robin Robinson.
Robin Robinson, Ph.D., retired Director of BARDA
Dr. Robin Robinson was appointed in April 2008 as the first director of the Biomedical Advanced Research and Development Authority (BARDA), and Deputy Assistant Secretary in the Office of the Assistant Secretary for Preparedness and Response within HHS.
Dr. Robinson previously served from 2004-2008 as the Director for the Influenza & Emerging Disease Program within BARDA and its predecessor agency at HHS. Dr. Robinson was recruited by HHS from the vaccine industry in May 2004 to establish a program with scientific and technical experts to implement the strategic plans and policies for medical countermeasures outlined in the National Strategy for Pandemic Influenza. These measures included development, acquisition and establishment of national medical countermeasure stockpiles, and expansion of domestic manufacturing surge capacities for influenza vaccines, antiviral drugs, rapid diagnostics, and non-pharmaceutical countermeasures including respiratory devices. Dr. Robinson received a Bachelor’s degree in Biology from Millsaps College in 1976, a Doctoral degree from the University of Mississippi Medical School in medical microbiology, and completed in 1983 a NIH postdoctoral fellowship with the State University of New York at Stony Brook in molecular oncology.
As Director of Vaccines at Novavax, Inc., he developed patented platform vaccine technologies. Dr. Robinson also serves on World Health Organization (WHO) international expert teams on pandemic influenza vaccines."
Is it just a coincidence that the new game changing NA study was just released as newly retired Robinson makes his keynote address?
Is see GREEN by the end of the day with plenty more GREEN in the coming months.
Check this out:
Robin Robinson helped create the NVAX VLP/Recombinant Platform you see today, along with Gale Smith and others and was part of the first group (NVAX), to show promising NA data.
I think after the FBR conference today, NVAX will close in the GREEN (now 5.19)
Hi Itdobanion, This is what Stan said on Feb 29, 2016 at the CC:
"Last year we reported data on the 206 trial, which is very good data on all 4 strains,
and...but in addition both on the work of our nanoparticle vaccines for RSV and Ebola, and additional data that we got from Flu, we're talking to BARDA about what the pathway to licensure should be, with a Flu vaccine based upon what we've learned, and we're thinking about making changes to it, and what those changes would have on the impact on the design of the next trial. So that's what we're talking about, we're conducting some animal studies, we'll have some data in a month or two, and we'll give you a much more definitive answer at that time."
The next CC will be early May for the Q1 review. So, I would expect that to be the latest date we get the flu update. Hopefully sooner. This NA news will likely be discussed too. (How could they not?)
And yes... the weather is finally perfect up here in PA. Cheers.
Excellent! Thanks Wolverine.
"Based on these findings, the authors suggest that the role of NA immunity should be considered when studying influenza susceptibility and that NA antigens should be considered in the design of future flu vaccine platforms."
With 'retired' BARDA Director Robin Robinson meeting with NVAX today at the FBR conference (and delivering the Keynote speech)... AND, the expected (any day now) update to NVAX's Flu program... This is very interesting!
I've said it before the only reason Big Pharma doesn't talk about NA is for the same reason they don't talk about RSV... It's because they can't.
Things are looking up!
The FBR Conference with Team NVAX & RR is on Wednesday, 4 20 16
As a reminder... Novavax had its “Outperform” rating reiterated by analysts at FBR Capital Markets on March 1st 2016. They now have a $17 price target.
Hmmmm. Retired' Director of BARDA hooking up with NVAX again... One of the KEY players in the history of NVAX with his name on the VLP patents.
NVAX Q1 meeting in less than a month as we eagerly await an update on the Flu program.
(Quad & Pandemic.)
Meanwhile in China, the 4th 'Family Cluster' of H7N9 was just reported in 2016...
(H7N9 is why we have the BARDA contract and the FDA Fast Track)
So many possibilities... Is RR coming back to NVAX? If so... is it because Robin recognizes an opportunity of a lifetime now that the platform he helped create has been thoroughly validated? Does this free up our BARDA relationship for additional funding? Is FBR going to upgrade NVAX in the Guggenheim range of $25+?
Stan said this was going to be an incredibly exciting year... I believe him.
How much clearer can Stan spell this out? Simply duplicate Ph2 RSV on a larger scale. That's basically what this Ph3 Resolve trial is all about and the FDA is clearly onboard. Unlike flu, RSV has been very stable & predictable over the years. If the unblinded data 'were all great in Ph2', they will almost certainly be as good if not better for Ph3.
Also... I think Stan or Glenn hinted that it may even help us that we had a rather mild flu season but a normal RSV season for the Ph3 Resolve trial.
It's no wonder why everyone is so confident & incredibly excited. (Except for the shorts & BP.)
Read the Needham transcript... 64% reduction in moderate to severe RSV which is what the FDA is looking for.
NVAX will have the only RSV vaccine on the market to prevent 64% of moderate to severe RSV in vaccinated adults. (based on Ph2). If you don't think that is extremely significant, you don't have a clue. You're spouting more BS. Why should you care if thousands of people suffer and die needlessly? You're stone cold.
Exactly the way I see it Albert. I'm sure you also remember the thread created by biopronvax on flu yield after the Feb 29 CC. That was a gift...
If there was any issue with Quad Flu, NVAX wouldn't be so excited with the RSV/Flu combo vaccine.
The vaccine that will CHANGE EVERYTHING.
I also like VLP / Flu pioneer and ex BARDA, ex NVAX, Robin Robinson rubbing shoulders with Team NVAX twice in the next 5 days.
Yup... Early May at the Q1 CC at the latest for Quad Flu updates... Hopefully sooner!
If you had truly been paying attention, you would know that the reason NVAX has employed the go it alone strategy up till now, is the they could bring RSV vaccines to the market ASAP. Stan has said that other companies would slow them down. It's hard to argue with Stan/NVAX as they are the first and only company in history to have two Ph3 RSV vaccines. Now that they have reached Ph3, with commercialization in place and key new hires like Bob Darius, Stan said that NVAX will use overseas partners as they launch RSV Resolve here in the U.S. With the "blessing" of the FDA (according to Stan), how much faster could they go?
As far as RSV Prepare, we have $89M from the BMGF, backed by the world's wealthiest man and the number one most influential person in Vaccines on the planet.
All joking aside, you have no business talking about ethics... Not only did you fabricate a negative story about NVAX and claim it was from the Motley Fools, it is your sole purpose in life to derail / delay a company that will save thousands if not millions of lives. What's a few thousand lives, right? Why should you care that thousands of people will suffer and die as long as you can make a few more pennies.
Maybe I'm being to harsh on you... At least you finally realize NVAX had a "miraculous" vaccine that will save thousands of lives. You've got that part right.