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Very good presentation, the most important info for investors being contained in slide 27, "2014 Goals." Important to note that the expected timeline has not changed... human clinical trials expected to start,"best case" Q4 of next yr or "at worst" Q1 of 2015. Very short trials... (summarizing), "2 wks for Phase I plus 1 week to garner the data." Tox done around "midyear" and then the drug will be available for compassionate use.
The biggest percentage increase in the stock price will occur between now and the time the company completes Phase IIa. That could be a very short journey, relatively speaking, considering the size of the payoff that will occur on completion of the early trials and in anticipation of approval. That should happen in 2015 and I believe, using industry comps, would value the company north of $10B (A successful flu drug would probably do at least $2B in annual sales). That's a share price of about $200 and would be based only on FluCide. Subject to working in humans of course.
Assuming all goes well through early trials, the biggest profit in the stock will be made before a dime of profit on sales.
as we have seen in numerous biotech examples, turning a profit is not necessary to get "rocketing upwards." Companies can reach upwards of $10B market cap with zero profits.
When are the shorts going to start to cover?
As expected, short interest still minuscule as of mid month report (about 335,000 shares) and up only slightly despite "Hard To Borrow" notation. I don't expect much different on the EOM report.
nor has any product he's been involved with gained FDA approval or been distributed in the US
I think too there was a lot of resistance by organized gay groups who were employing a lot of people in anonymous testing centers and charging many times the cost of this test strip solution to draw blood and return the results a couple of weeks later.
The problem is, once a company responds to such nonsense they are then put in a position where they are obligated to respond every time some idiotic short piece gets put out there or someone will think, "Oh, maybe this one is true." Here's what Doc Seymour says about this --
"Oh, got to go..one of my patients is barking!"
Perfect.
True, but the company has updated progress publicly several times, reiterating the timeframe for scheduled completion. Unless that changes at some future point I don't think there is any reason to not assume everything is on track.
see posts from nnvcbob, he has been posting first hand accounts of the construction activity there. Things have been hopping along just fine. Otherwise we have been told by the company that the facility is scheduled for completion in Q1.
apparently she has quite a history --
http://www.techdirt.com/articles/20130406/17144322611/teri-buhl-jurno-private-tweeter-lawsuit-enthusiast-sentenced-to-30-days-jail-harassment.shtml
http://www.techdirt.com/articles/20130207/10425321911/teri-buhl-threatens-to-sue-us-others-still-seems-confused-about-law.shtml
maybe she was writing from jail? Here's a nice character reference --
Buhl gets 30 days jail time, probation and ordered to stay away from victims' family
http://www.newcanaannewsonline.com/news/article/Buhl-gets-30-days-jail-time-probation-and-4410428.php
she's quoting a known short seller... So you know which side of the ledger she is on and you can bet she has no interest in anything positive about the company. Nobody spews that kind of negative innuendo without an agenda... "The lawsuit says...", "The short seller says...." Very superficially done and yet she calls herself a "professional financial investigative journalist." A complete joke.
But these articles were out at the end of Oct and obviously did not have their intended effect. But she'll probably keep trying...
What a load of crap. Obviously meant to distort and mislead in support of a short position. First of all, Dr. Seymour is not a veterinarian. You'd think he could at least get that much right, which tells you where the rest of it should be filed. Maybe he thinks the Doc tested those 5,000+ animals in the back room of his vet clinic? And the lawsuit was filed by Brambell alone, not a group of investors. It has already been dismissed several times but apparently he won't go away.
Diwan cashed out his early investment in NanoViricides two years ago and used the proceeds to buy land in West Haven, Conn., to develop a government certified research lab for NanoViricides.
The building will only be leased by the biotech company, yet the company is spending money to build it out and has pledged $2.5 million of collateral towards completion of the project.
Yet last month the budding development company was still able to raise over $10 million through Midtown Partners with a private after market stock sale called a registered direct offering.
The RDO was offered to institutional investors at a discount of 26% percent. This means they can buy the stock after the close at the discounted price and then sell it into the market the next day at a profit. It creates trading volume in the stock but not necessarily long term value for main street investors because the hedge funds who buy the deal usually just dump the stock.
2500 shares just traded at $5.21 (+15%) after hrs. A bit of a hosing I would say.
they know nothing more than they did when making their last prediction that it was headed to 20 cents just before it launched about 5-fold. It comes from a serial basher that has a personal beef with Dr. Seymour.
Yes, under the right circumstances the stock could easily drop back below $4 with no change in fundamentals. That should not alarm anybody invested in this type of stock.
Well, yes of course. But from last reported levels I doubt you suddenly see outlandishly large accumulated short interest on the mid month Nov or EOM report. We'll see in a few days for the Nov 15 report. Right now there is algo selling in the stock... a few hundred hit the bid every minute.
since the Flucide application is broad spectrum that would almost certainly have included MERS as well.
very low short interest as of last report (Oct 31st).... 321,000 shares is less than 1% of the float.
Ok, I think I see where the confusion is emanating. FluCide will be marketed as a universal treatment for the flu, effective against all flu strains. To prove universal effectiveness and to be marketed that way, the FDA required them to test, and show efficacy against, 16 flu strains (4 of them in vivo). This is different than saying it is broad spectrum (ie that it could be marketed initially against other viruses as well, as was suggested below). Though as I understand it, the base micelle has shown some effectiveness in that regard, and perhaps down the road could be used for something else. But I think that would require further testing.
The agreement with PHE was for both and both require the same applications, biohazard 3 or 4 facility and the same work and same animals just with differnet viruses.
yes, I was not saying otherwise, but responding to this statement --
The FDA has nothing to do with it until there is a pre IND meeting (which has already been done for H7N9 and, since the Flucide application is broad spectrum that would almost certainly have included MERS as well. So there is nothing further that either NNVC nor the FDA can do until the testing by PHE is done.
I believe the delay has been primarily related to the extensive amount of paperwork required... confidentiality agreement, sending and review of prior results, permission from the WHO to use the virus for testing, and then a formal proposal submitted by PHE to NNVC covering the testing itself followed by review and modifications to the proposal if necessary. Only after this is accomplished can the drug be shipped and the study begun.
MERS is a separate cide that I presume will require separate testing.
and I guess they are not aware that a biotech company can receive a market cap well into the billions without a penny in sales or earnings.
I expect nothing but random movement of the stock price until tox tests are completed.
Yes, the treatment will be approved, marketed and sold as a universal flu treatment. 16 strains as I recall required to be tested by the FDA to get that designation, 4 of them in vivo. (The additional efficacy testing stipulated by the FDA at the pre-IND meeting). Post approval, the efficacy for any new strain would effectively be demonstrated in human patients.
there is no no real debate on whether humans are causing the planet to warm..97% of climate scientists agree..
97% of all QUALIFIED scientists working related areas agree both that global warming is very real and that humans are the primary cause (i.e.: responsible for >90% of the increase.
Peer-Reviewed Survey Finds Majority Of Scientists Skeptical Of Global Warming Crisis
2/13/2013 @ 1:19PM
It is becoming clear that not only do many scientists dispute the asserted global warming crisis, but these skeptical scientists may indeed form a scientific consensus.
Don’t look now, but maybe a scientific consensus exists concerning global warming after all. Only 36 percent of geoscientists and engineers believe that humans are creating a global warming crisis, according to a survey reported in the peer-reviewed Organization Studies. By contrast, a strong majority of the 1,077 respondents believe that nature is the primary cause of recent global warming and/or that future global warming will not be a very serious problem.
The survey results show geoscientists (also known as earth scientists) and engineers hold similar views as meteorologists. Two recent surveys of meteorologists (summarized here and here) revealed similar skepticism of alarmist global warming claims.
According to the newly published survey of geoscientists and engineers, merely 36 percent of respondents fit the “Comply with Kyoto” model. The scientists in this group “express the strong belief that climate change is happening, that it is not a normal cycle of nature, and humans are the main or central cause.”
The authors of the survey report, however, note that the overwhelming majority of scientists fall within four other models, each of which is skeptical of alarmist global warming claims.
The survey finds that 24 percent of the scientist respondents fit the “Nature Is Overwhelming” model. “In their diagnostic framing, they believe that changes to the climate are natural, normal cycles of the Earth.” Moreover, “they strongly disagree that climate change poses any significant public risk and see no impact on their personal lives.”
Another group of scientists fit the “Fatalists” model. These scientists, comprising 17 percent of the respondents, “diagnose climate change as both human- and naturally caused. ‘Fatalists’ consider climate change to be a smaller public risk with little impact on their personal life. They are skeptical that the scientific debate is settled regarding the IPCC modeling.” These scientists are likely to ask, “How can anyone take action if research is biased?”
The next largest group of scientists, comprising 10 percent of respondents, fit the “Economic Responsibility” model. These scientists “diagnose climate change as being natural or human caused. More than any other group, they underscore that the ‘real’ cause of climate change is unknown as nature is forever changing and uncontrollable. Similar to the ‘nature is overwhelming’ adherents, they disagree that climate change poses any significant public risk and see no impact on their personal life. They are also less likely to believe that the scientific debate is settled and that the IPCC modeling is accurate. In their prognostic framing, they point to the harm the Kyoto Protocol and all regulation will do to the economy.”
The final group of scientists, comprising 5 percent of the respondents, fit the “Regulation Activists” model. These scientists “diagnose climate change as being both human- and naturally caused, posing a moderate public risk, with only slight impact on their personal life.” Moreover, “They are also skeptical with regard to the scientific debate being settled and are the most indecisive whether IPCC modeling is accurate.”
Taken together, these four skeptical groups numerically blow away the 36 percent of scientists who believe global warming is human caused and a serious concern.
One interesting aspect of this new survey is the unmistakably alarmist bent of the survey takers. They frequently use terms such as “denier” to describe scientists who are skeptical of an asserted global warming crisis, and they refer to skeptical scientists as “speaking against climate science” rather than “speaking against asserted climate projections.” Accordingly, alarmists will have a hard time arguing the survey is biased or somehow connected to the ‘vast right-wing climate denial machine.’
Another interesting aspect of this new survey is that it reports on the beliefs of scientists themselves rather than bureaucrats who often publish alarmist statements without polling their member scientists. We now have meteorologists, geoscientists and engineers all reporting that they are skeptics of an asserted global warming crisis, yet the bureaucrats of these organizations frequently suck up to the media and suck up to government grant providers by trying to tell us the opposite of what their scientist members actually believe.
People who look behind the self-serving statements by global warming alarmists about an alleged “consensus” have always known that no such alarmist consensus exists among scientists. Now that we have access to hard surveys of scientists themselves, it is becoming clear that not only do many scientists dispute the asserted global warming crisis, but these skeptical scientists may indeed form a scientific consensus.
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For anyone who still doubts that global warming is both real and a VERY severe danger: (Dengue (and malaria) will be only a very very small part of it).
And now it's global COOLING! Return of Arctic ice cap as it grows by 29% in a year
533,000 more square miles of ocean covered with ice than in 2012
BBC reported in 2007 global warming would leave Arctic ice-free in summer by 2013
Publication of UN climate change report suggesting global warming caused by humans pushed back to later this month
By David Rose
PUBLISHED: 18:37 EST, 7 September 2013
A chilly Arctic summer has left 533,000 more square miles of ocean covered with ice than at the same time last year – an increase of 29 per cent.
The rebound from 2012’s record low comes six years after the BBC reported that global warming would leave the Arctic ice-free in summer by 2013.
Instead, days before the annual autumn re-freeze is due to begin, an unbroken ice sheet more than half the size of Europe already stretches from the Canadian islands to Russia’s northern shores.
The Northwest Passage from the Atlantic to the Pacific has remained blocked by pack-ice all year. More than 20 yachts that had planned to sail it have been left ice-bound and a cruise ship attempting the route was forced to turn back.
Some eminent scientists now believe the world is heading for a period of cooling that will not end until the middle of this century – a process that would expose computer forecasts of imminent catastrophic warming as dangerously misleading.
The disclosure comes 11 months after The Mail on Sunday triggered intense political and scientific debate by revealing that global warming has ‘paused’ since the beginning of 1997 – an event that the computer models used by climate experts failed to predict.
In March, this newspaper further revealed that temperatures are about to drop below the level that the models forecast with ‘90 per cent certainty’.
The pause – which has now been accepted as real by every major climate research centre – is important, because the models’ predictions of ever-increasing global temperatures have made many of the world’s economies divert billions of pounds into ‘green’ measures to counter climate change.
Those predictions now appear gravely flawed.
The continuing furore caused by The Mail on Sunday’s revelations – which will now be amplified by the return of the Arctic ice sheet – has forced the UN’s climate change body to reconsider its position.
I'll see if I can get him to commit to meeting everyone in Hawaii
Welcome aboard. The holidays must be fun...
they just optimized their lead HIV candidate in Sept, so I would say it is getting a bit of active attention now.
robiwon -
Yes, separate tox and trials have to be run for the oral version.
The easiest way to price the market is to look at current sales of TamiFlu and Relenza. A drug that actually works is expected to exceed those in sales, hence management's estimate of $4-$7B in annual sales. Just take a conservative whack at something around $2B in global sales and you get into the same $9-$10B ballpark as PCYC. $10B equates to a share price around $200.....that's enough of a nosebleed that you don't need to get wild with your projections. Of course that would be the projection on FluCide alone, giving zero value to the other pipeline candidates.... and zero value as well to the the ability to create anti-virals on demand.
Importantly, note that this company had a market cap of around $9B prior to approval. Assuming things go smoothly from here, we will probably see similar anticipatory pricing after a successful combined Phase I/IIa.
Here's an example today of an approval after Phase II under Breakthrough Therapy designation --
Pharmacyclics Drug Wins One Approval, Awaits Another
By AMY REEVES, INVESTOR'S BUSINESS DAILY
The Food and Drug Administration approved Pharmacyclics' (PCYC) cancer drug ibrutinib Wednesday, but it only cleared one of the two diseases the company had applied to treat.
The FDA approved the drug, now renamed Imbruvica, to treat mantle-cell lymphoma, a rare form of lymphoma currently treated with Celgene's (CELG) Revlimid and Takeda's Velcade.
It's only the second product to be approved under the agency's new "breakthrough therapy" designation, which allowed a decision to be made after only two phases of clinical trials instead of three. However, it didn't mention the part of Pharmacyclics' application asking for approval for chronic lymphocytic leukemia.
Analyst Michael Yee speculates the FDA might be waiting for data from an ongoing clinical trial called Resonate-1, expected in January, before it makes its final decision on CLL.
"Recall that we think inclusion of Resonate-1 data could actually be positive, as it would give physicians randomized data against (GlaxoSmithKline's (GSK) Ofatumamab to base prescribing decisions on, with better attribution of side effects to drug," he wrote in an e-mail to clients. He said the possible delay would be "immaterial" for 2014 estimates, and also noted that the FDA's comments had included no serious safety warnings.
The delay might also leave a bit more wiggle room for Gilead Sciences' (GILD) CLL candidate idelalisib, which reportedly did so well in its phase-three trial that Gilead ended it early last month.
The drug's launch and marketing will be handled by Johnson & Johnson (JNJ) division Janssen Pharmaceuticals.
As IBD reported last month, hopes that ibrutinib will be a blockbuster more than doubled the Pharmacyclics stock price this year, though it now trades 13% off its all-time high above 143 hit on Oct. 4. Pharmacyclics stock was down a fraction in morning trading in the stock market Wednesday, but the stock was up 4% in afternoon trading, after the FDA news broke.
Thx -------
bgrosh@bendbroadband.com
Forz -
Well, I certainly don't want to be left out of the planning! But I think I need to be a Facebook member to get in? I'm not a member there.
A $268M market cap at this juncture would indicate that we are getting a fairly good dose of respect.
yes, my point is that since the FDA approved orphan designation there was little doubt EMA would approve the designation as well. Stock prices are a game of expectations.... you need to exceed them to get an increase in share price. In this case they were merely met.