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I am wondering how Tiva compares to EXEL's Cabo, which was claimed to be 2+2=10, egfr+met?
In the whole history of evolution, our immune system is the product of parasites, bacteria and virus. Without them, our immune system has gone haywire.
I believe worms benefit our body in some way. Next develop will be some low-symptom immune-system-boosting bacteria.
Oraquick acceptance
OSUR stock price performance indicates oraquick may not sell. I scratched my head and can't figure out whether it's a marketing or cultural, or even public policy problem.
Hygiene hypothesis
National Institute of Allergy and Infectious Diseases may really want to test this hypothesis. I guess CNDO is the only one who has this kind of clinical trial running. It's a gamble for investors.
I am long but I remain cautious. This OS issue is a billions dollar question. If XL184 can make OS significantly higher, it will be a big blockbusters. Otherwise, a niche market for bone metastasis.
So simultaneously inhibiting EGFR/MET like XL184 sometimes provide a worst evolutionary pressure to the cancer stem cells and make them revenge very badly?
OS question EXEL must answer
It is a dual(or multiple) inhibitor. In the MTC trial, why did it has a very long PFS, not OS?
from yahoo msg brd.
In his study, Dr. Raghu Kalluri found out with sole EGFR inhibitors "a fivefold increase in activation of Met, a receptor molecule that promotes cell migration and growth". And, "Additional experiments showed that combining pericyte-depleting drugs with the Met-inhibiting drug helped suppress EMT and metastasis".
I don't understand in EXAM, PFS didn't reflect on OS, 4mo vs 11mo was too big a difference for anything like OS data are not matured. Our MET inhibition is not strong enough or there is other path revengefully come back?
Inner city asthma rates- the link there at least to some extent is the correlation of AA race and vitamin D deficiency with asthma
most immigrants may support this idea
me included. Before I came to US to attend graduate school, I didn't have problems with allergy. In the first few years in US, I didn't. My siblings and parents don't have. That's not only my problems, almost everyone with my immigration background around me experienced the same.
The company may have a lot of challenges to face and may fail. But the hypothesis and its perspective in immune therapy, IMHO, will have a bright future.
Good drug candidate, and bad CEO/CFO.
Is CNDO last low hanging fruit?
As an immigrant to the US for about 20 years, I am a firm believer of hygiene hypothesis. Me, and my fellow Chinese friends, basically without exceptions, developed allergy symptoms after 5-10 yrs living here. And our parents and siblings back in home didn't. And other research showed the same trend. For example, no Thailand newborns have autism and American newborns' cases are booming. Americans have much more immune system diseases than those "dirty" countries.
We human beings and our non-human ancestors developed our immune system against bacteria, virus and parasites in our long evolution history. Unfortunately, it seems that we still need bacteria, virus and parasite to stimulate the health of this symtem.
CNDO may open a big door to fighting our very modern "clean" diseases. And it may be the last one normal people can understand by guts.
My concern is how they protect their drug. Any hospitals and companies can easily find their own worm to swallow. Also they have to find a no-disease-causing-but-immune-stimulating bacteria(TH1) to balance parasite TH2 path.
OSUR market potential
Will OSUR at home HIV test be accepted by sexual-active Americans? Seems it's a psychological or marketing question, not a science one.
Why not buy MYL, who has about the same best reputation as TEVA but with much smaller size. Now PFE is off the bidding war, will they go after MYL instead?
All these Insulin overdosing problems can be mitigated by adding Amylin into Insulin. I mean the hormone, not the company. Well the drug name of Amylin of the namesake company is Symlin. Amylin as well Insulin are excreted by islet. When your islet cells have problems, they don't excrete both hormones correctly. The best way is to take both, Amylin will take care of food intake regulation. Therefore, you take less insulin and get better result of sugar control, you developed less insulin resistance, immune system reactions, and less beta cells decay. Although FDA approved symlin for type I and II diabetes, it rejected the idea of mixing two hormones together for insulin taking patients. FDA is FDA, it always has some unexplainable political concerns.
AMLN's democratic coup d'etat didn't affect stock market. I think it's a good start to change the incompetent management.
ONXX and Bayer
Wonder how can a big phama modify its biotech partner product and get 100% of the next generation drug's sale. If there is a legal leeway to do that, all small bioteches shall be very careful. What probability can onxx win over it?
It will take 2-6 weeks, right? Since they have been preparing for that letter for months, I guess they will finish it in less than 3 weeks. After then, on July we will finish dyloject safety trial. Why did they believe dyloject filing will be first and ereska second?
Can it be considered as a cure if there is no free circulating HCV? With this antibody, the virus released from infected cell will be neutralized. After all viral particles leave the cell, can this cell be virus free and function as normal?
Hardly can vivitrol fail in that opiate indication. Naltrexone was originally designed for opiate addiction and then moved to alcohol. I don't know if alks longs should be happy or sad about that.
This unsuccessful of vivitrol came from good people against good people. A lot alcoholics helping groups and counselors are against using chemicals to help psychological diseases. It's very philosophical and religious. Something like if there is independent existence of spirit, free will and volition kinda stuff, if we should use chemicals to interfere with human mind. We know America is more or less a religious country, a lot of people believe in their mind powers. The result is refusing drug's help to overcome another drug addiction. And continue to kill themselves and other people. It's a sad but ridiculously true fact.
>>I think that's the corporate FDA ass kisser =)<<
Better than failures like ency and dsco
How much will ALKS make percentagewise on LAR?
It's like that:
For sale of $X on LAR
ALKS earnings: 0.075*X
AMLN, LLY earnings: (0.925*X-manuf-market-manage)/2
ALKS got the non-risky part.
AMLN proxy war
Anybody's watching the proxy war on AMLN field? Very dramatic and entertaining.
Also, do you think as the war getting intense ALKS will be a better biotech value play(value arbitrage against amylin) because of the 7% of byetta revenue?
It seems the NBIX endo result's p isn't any impressive. Marginal, my opinion.
Thanks, Intellekt. That explains a lot. You know I don't even want to sell my shares at $20, and my shares don't matter in any proxy war. That was my worry.
I don't know how the regulation handle privatization. Now efficacy controls the majority of vote. And it's for sure they want to buy as cheap as possible. For example, if they offer $8, it has some premium over current price and they vote YES on the deal. What can I do? My small number of NO votes doesn't matter, right? So is it easy for big holder to screw small holder this way?
So nobody knows the current status of anemia trial?
Help! Status of Anemia.
What's the current status of anemia trial? Enrolling? Finished enrollment? All are dosing? Or unblinded and analyzing? All I can get is 2H09 NDA. But you know, about 10 months ago, they still predicted NDA by the end of 08. CRO is working hard?
Thanks. Seems they finished Ereska trial on Nov. Why does it take so long to submit NDA? Analyzing data and filing forms and writing applications, I thought they have some experience with that.
So they now can fire european marketing people to save more cost. Did they update the progress for dyloject's safety and K's pivotal trials at JPM conference?
Why the little drop today?
These data are way so toooo good that FDA will block short term anemia usage approval. It will approve three indications in a batch after the long term safety data out. I can imagine huge massive off-label if this drug is on the market for prevention of anemia before surgery. That's what FDA hates. No low hanging fruit.
Shorts please bring it down more and depress it for some time. I like it since I won't sell it in 2 yrs. Low price is good for me.
At current price and in this investment environment, Efficacy may steal my shares at 50-100% premium. I am against it and my tiny amount makes no voice. Can I choose to be a tiny private shareholder instead of selling my shares to efficacy at $20? I want $100 though I know nobody would offer that much for now.
How near is near term? The major news can also be approval of change manufacturer for dyloject, phase 3 top line or even K's finishing enrollment, if there is no partnership announcement.
Did he sound frustrated? I am really frustrated. If I can find a ten bagger, I would be hilarious. But with this one, I will break even. Does JAV selling subprime mortgage or something?
Can we assume this trial will be finished in one month?
Obviously, these patients can only be eligible after physicians planed an ortho surgery. Add 5 more days for dosing. So in at most 30 days we will unblind and be into analysis phase?
What happened? Anemia Phase III failed in some way?
I guess this phase 3 may have financial problems. For example, they recruited 500 patients and after the treatment, 497 women or their doctors considered their UF were cured so no need to go to surgery. They have to recruit millions patients to have enough subjects to prove proellex is good for pre-surgery. Very tough for a drug to be too efficient.
Or, they talked with FDA about this phase 3. FDA said, there are huge possibility this anemia drug will be used off-lable, we have to wait for more safe data.
Or, what's your guess?
Thanks bio_pete and DewDiligence for your reply. From today's PR, we can see there were six-month mouse and 2-year rat carcinogenicity study. So I assume these are the two-species trials the company is talking about. If one of them is not requested by FDA, why the company bother with another rodent. Or these two rodents are considered to be one specie? And we need to finish dog or monkey or whatever mammal requested by FDA?
Two-species mean mouse and rat, mouse for 6 months and rat for 2 years, right?
Question about anemia trial.
It's a pre-surgical trial. And we already knew that proellex is good for UF. So we can assume that a lot of women happend to be on proellex may not have to do UF surgery as planed after anemia trial. What's the plan for these women? 1) Continue with open label trial so that they will stay away from surgery or 2) stop and wait for symptom to get back and do surgery?
Please gimme some Special-K. I need it and my JAV shares need it. At current share price, no shareholders can afford it. Please give every share holder a chance to take part in the special-K open label long term trial.