Dr. Davis is a good guy and an asset to the company. He was voted off the board because no one knew about him prior to last year's stockholder meeting. At the meeting (and after the vote), he showed great knowledge of the company and its markets. I think if people had known about more about him before the vote, the result would have been different.
There is a large community of day traders who like to trade the hottest stocks. The term "momo players" is used to describe them, because they buy stocks with "momentum". You see brokerage ads on CNBC promoting "trading platforms", geared for this crowd. They like to communicate and promote to help each other out, one way is through Twitter. I just looked at Twitter, here are a few recent messages.
Tom Minnich @thomas_minnich · 15m
@AjTrader7 fyi... $NKTR & $BIOD are break-out. I like these longs today.
StockAddict @abuabdulmujeeb · 16m
$NKTR running as told :)
Nikki Dunn @FitTraderChick · 16m
I should have listened to @ChrisDunnTV .. closed $NKTR too early lol ..sorry honey
Last year I actually did look up Smith, he was still actively posting on other boards, but now I don't remember which ones.
Good luck to you!
Biotech is white hot these days, especially among momo players. NKTR was mentioned often in the Twittersphere this morning prior to the open as a stock with strong momentum. Enjoy the ride!
They hired an experienced hand to manage the Australian and New Zealand properties. Hopefully he can extract additional value.
William P. Forbes - Chief Development Officer and Executive Vice President of Research & Development
Right. And let me see if I can handle the RELISTOR questions. I'm a little hesitant to say anything about RELISTOR dates given the fact that they've already had. Because of the scheduling conflicts cancel the last one that was going be coming up here in March. But it looks like now it may be near the end of May, is one of the new date -- or 2 days will be. But I think right now, it's a little early, until everybody has a chance to weigh in if those dates are acceptable. But I think it's -- you can look possibly towards the end of May at this point in time.
By way of comparison, here were the BIIB Phase III topline results.
In the A-LONG study, 165 male patients aged 12 years and older were enrolled. The A-LONG study had three treatment arms: individualized prophylaxis, weekly prophylaxis and episodic (on-demand) treatment (Arms 1, 2 and 3, respectively). In a subgroup of patients across treatment arms, rFVIIIFc was evaluated in the perioperative management of patients who required a major surgical procedure during the study.
Overall, 93 percent of patients completed the study. Recombinant FVIIIFc was generally well-tolerated. No inhibitors to rFVIIIFc were detected and no cases of anaphylaxis were reported in any patients, all of whom switched from commercially-available Factor VIII products. No serious adverse events were assessed to be related to drug by the investigator. The most common adverse events (incidence of ≥5 percent) occurring outside of the perioperative management period were nasopharyngitis, arthralgia, headache and upper respiratory tract infection.
The median annualized bleeding rates (ABR), including spontaneous and traumatic bleeds, were 1.6 in the individualized prophylaxis arm, 3.6 in the weekly prophylaxis arm and 33.6 in the episodic treatment arm. In the individualized prophylaxis arm, the median dosing interval was 3.5 days. During the last three months on study, 30 percent of patients in the individualized prophylaxis arm achieved a mean dosing interval of five days.
BAX-855 will compete against Bayer and BIIB products.
134 subjects were treated in the study. Subjects selected either on-demand or prophylactic treatment upon enrollment. All subjects in the three prophylaxis arms began treatment with the site-specific PEGylated recombinant human factor VIII twice per week. After a ten-week period subjects experiencing more than one bleed during this assessment period stayed on two infusions per week at a higher dose and all other subjects were randomized to either every five- or seven-day treatment for six months. After randomization, subjects who assessed their bleeding control as not adequate could leave the assigned treatment regimen and increase their infusion frequency.
88 percent of subjects met the pre-defined criterion of bleeding control in the ten-week initial assessment period and qualified for randomization. All subjects receiving infusion every five days (n=43) remained in this treatment arm. 44 percent of subjects in the every-five-day treatment arm experienced no bleeds. A median annualized bleeding rate (ABR) of 1.9 was observed in this treatment arm. 74 percent of the subjects receiving infusion every seven days (n=43) remained in their treatment arm. 37 percent experienced no bleeds. A median ABR of 3.9 (including non-completers) was observed in this treatment arm. The 13 subjects who remained in the two times per week treatment arm, because of their high bleeding rate during the assessment period, reduced their median ABR from 17.4 to 4.1 following dose increase. By comparison, subjects who were treated on-demand (n=20) had a median ABR of 23.
Detailed data are scheduled for presentation at the World Federation of Hemophilia Meeting in May 2014 in Melbourne, Australia.
According to a letter I received from IR in 2012, there is no milestone payment for Levadex approval. Royalties are likely in the 3-5% range like other contracts from that period.
NKTR is a news story company, not an earnings company. If the stock moves higher in the next couple of years, it will be because of successful clinical trials and drug approvals, not sales and profit. The earnings risk is if the company burns cash too quickly, leading to yet another dilution.
What typically happens is that the control group performs much better than expected.
Biotech investors with a decent memory have heard "the clinical trial is taking longer than expected so it means good news" theory before. Unfortunately, reality almost always rudely interrupts.
Remember Vical (VICL) and its melanoma vaccine Allovectin? Vical bulls insisted Allovectin was a winner because the phase III study was taking so long to read out results. Wrong. Allovectin failed.
Then there was Stimuvax, the lung cancer vaccine developed by Oncoythyreon (ONTY) and Merck KGaA. The analysis of the Stimuvax phase III study was also delayed by a slower death rate, but it didn't matter. The Stimuvax study eventually failed.
Ziopharm (ZIOP), Celsion (CLSN), Keryx (KERX) (perifosine), Genta (Genasense), Cell Therapeutics (CTIC) (Xyotax) -- all conducted phase III studies of cancer drugs that took longer than expected to reach the predefined time point for analysis. All failed.
I'd love to cite an example of a successful and delayed cancer drug trial but I can't think of one.
As far as I know, a new AdCom date hasn't been set. SLXP reports after close on Feb. 26, I'm sure that will come up in the discussion.
-- "On another note the sky is blue, and grass is green."
Here the sky is perpetually gray. There's been snow covering the grass for the past 2 1/2 months. It's probably brown underneath.