Have u looked up lifevax, vet in NY offers this technology, no clue on cost etc., but has had some good results. Lifevax is owned by Tucan capital.
last sentence should say life expectancy greater than 3 months, greater than sign is getting deleted by yahoo.
Just went to trials.gov. Basically they get the Direct patients when they are DONE, no hope left, and are also done being destroyed by radiation and chemicals...
Must have completed at least one and no more than four treatment regimens in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden. Treatment must have been discontinued at least 14 days prior to initiating leukapheresis.
Any steroid therapy 2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter ≥ 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
Adequate hematological, hepatic, and renal function,
Adequate blood coagulation parameters
Life expectation of 3 months.
Oppenheimer, the analyst being cited in the article underestimates Opko but first here is his breakdown:
Analysts estimate that the 4Kscore has a value of about $ 5 per share. The 4Kscore intended to diagnose prostate cancer, is expected to market to about a million customers, and will also in the long term a much broader market of about 30 million customers, according to Oppenheimer.
Other products that add value are Claros-1 (a value of $ 2.5 per share), Rayaldy in a Phase 3 clinical trial right
now (about $ 4 per share) and hGH-CTP ($ 1.5) per share.
The sum of the parts value given indeed = 13. That said it all depends on the ultimate revenue of each of these products. This 13 dollar target is using bare minimum market penetrations, I think Rayaldy could top out at 1 billion in sales, he is likely using in the 250 m range. He also has not taken into account the testosterone test or psa tests. 30 million 4k tests is generous, but on a global scale maybe, if so that is over a billion in sales.
The bottom line is 13 is more a 2014 target I am sticking by 30 year ending 2016, if 4k is indeed doing 30 million unites I am WAY low.
Does the Direct use chemo and radiation? I think glioma is one of the listed cancers that might get enrolled.
The PEI signed the DCVAX document on 2/14, over the next 7 trading days the stock RAN 2.00 on no news, that is a huge 5.25- 7.25 move, hmmm, before the Reuters news article came out to set the short term high. A 2.00 move on news that may have trickled out in Germany, so not only has NWBO hung tough when the EU markets are open, the early run from 2/14 until 2/21 is curious. 2/21 is when nwbo got notified so I think this 2.00 move was likely foreign buyers, yes all speculative, but if it walks like a duck.
Noticed that we stay strong, or even up until the European markets close, then weaken. Potential revenue model for Germany likely being worked out with more solid data once NWBO gives a price.
Drs. and patients in Germany KNOW there IS NO DOWNSIDE using DCVAX. It might cure, and it will not harm the patient, MIGHT as WELL try it, without it Patients have no other OPTION at ALL and NO HOPE to survive.
A new thought is if it was included in the initial study and they made the FDA aware they were EXCLUDING it now, and they were given the go ahead, then the data gets included. Being 90 days in and waiting on DMC has me looking under rocks, thought this wafer thing might be the issue, but who knows.lol.
If the gliadel wafer was used prior, part of that, or all of that data might get thrown out, so that was why I mentioned it to begin with. I thought it could be the reason for the delay. Keep in mind NWBO data was excellent in the early study, and the wafer would have hurt the data, so NWBO data would have been EVEN better. Regardless though, if it was indeed included early, but excluded now, the early data gets tossed and we are not at 66 events. That is why I bought it up. It was a thought based on the slow data read by the DMC, but NWBO can argue to include that data since it would have lowered not raised efficiency. If I was checking the data I would be compelled to TOSS all patients who had the wafer. SAD is WE do not know if even one did, but a thought I had. Just found it strange Linda mentioned it, knowing in my mind if used it confounded the data.
We are in that 90 day range so realistically this data could hit any day. I initially bought into the two week thing until I started thinking about other companies and how that is near impossible. I know with other stocks I have owned it can take no less than 60 days. If they indeed need look at each and every MRI to VERIFY data, yikes. Think about when a phase 3 is completed to data release, it can be as much as 3-4 months. So I am only a little concerned. I mentioned the giladel wafers as a possible issue, others said it would not be, so the only other reason is daunting time consuming data.
I do not anticipate a stop for efficiency, a continue, WHICH THEY have at this point, we will see. A stop for futility is not an issue. Figure this way, if there are 66 events, of those how many are from the early data, and that data was very good. I hope they do stop for efficiency, but I am trying to be as objective as possible, and when you are long, ain't easy. The easy thing is to think GO NWBO lol.
Linda gave the shorts a hammer with her two week time line, hopefully the data takes their toy away.
One argument was lack of coverage from non Opko affiliated brokers, Opp is now on board.
Claros device is garbage, opko does a deal for hardware, has a mobile app, device is now in 10 languages.
Tesaro, Rolapitant is going for NDA, LW said phase studies would fail, oops, wrong.
Pending movement in England to do away with prostate biopsy, 4k as standard care, could happen, not yet.
His argument that all these little pharmas Opko owns are WORTHLESS, well they are generating NEAR 100M a year in revenue. 100 million revenue is not bad at all for worthless.
4k will likely not get launched for a year if ever, oops, any day now, insurance news pending.
Opko will never make money, well, they only lost .03 last q, ending the year with more cash than they entered the year, paper losses outstrip REAL cash burn enough cash to last until 2016.
Opko invests in garbage companies, well, one sale put 20 million back into the cash pile.
Opko 2016 should be generating no less than 1 billion, pt 30, and as the portfolio timelines inches forward 1 billion could be the low target. The LW thesis is crumbling with each passing month. Frost building a power house, will take a little more time.
I am now laying odds at 50/50. I think this data is more involved if they have to look at each mri, from each patient, etc., asco has a shot of getting here first. Asco is now only 6 weeks off. If they accept the presentation we might be able to read it in 5 weeks.
The new rule will have no affect what so ever from what I could see. NCSS will no longer act as the clearing house, if anything it might promote more shorting. If you guys know more than I could dig up and think it will help I welcome the news.
I can copy and past right to yahoo, but I delete the hyperlinks and retype bypassing word. When I can I skip copying a hyperlink and get forced to do part 1 and two on occasion.
AF has a list!!! AF has a list !!! Who THE F is AF, a political science major who thinks he has a medical degree. Give us your LIST of HOW many times THAT jamoke has BEEN wrong!!!! So you FOLLOW AF, lol, that explains your ranks, pathetic.
What I do not know is if the phase 3 does not meet end points can the German Gov revoke it???
My take is NO, because if that was the intent they would have said it is allowed and covered by insurance until phase 3 is complete and NOT 5 full years.
Compassionate USE IS NEVER covered by insurance. In Germany the FEDERAL GOV, has MANDATED that this procedure will indeed be covered by their national insurance.
THOSE from ANY other country can go to Germany and for those patients in a loose sense it will be compassionate use, they will have to pay out of pocket.
Why there will be major uptake in GERMANY by German patients....
If you do not use the DCVAX you likely die in 18 months, so assume DCVAX does not ADD one day to your life, what have you lost ??? NOTHING.
Now assume you use DCVAX but instead of dying in 18 months you walk away cured and live a full normal life.
Drs. and patients alike can recognize an obvious WIN but can not lose scenario.
AF knows this, but he basically lied figuring to help his short position. Really pathetic.
incar where you R wrong is you are relying on AF and HIS determination that IT is COMPASSIONATE use. Obviously AF knows the definition of compassionate use but decided to distort the information any way. Compassionate USE is not covered by insurance, OUT OF pocket only. Germany has some form of national insurance and THE NATIONAL INSURANCE is paying for the treatments. BIG DISTINCTION here that AF deliberately distorted. Germany is welcoming patients from ANY WHERE in the world, BUT THEY will not be covered by insurance. So in that LOOSE interpretation there is NOW a COMPASSIONATE use for all the countries and people from any country if they go to Germany.
For the German people it is NOW a recognized medical procedure that their Dr. can recommend. It is in the patients and Drs. best interest to offer this treatment. With out it the patient might live 18 months, but if with it they still only live 18 months the patient and Dr. have LOST nothing. If the patient gets cured the Dr. and patient both win. The treatment OFFERS NO DOWNSIDE for the GBM patient, only upside. At worst they die on time, or live a full life, what would you do?
That said, look up Compassionate use, do not rely on AF who lies, and distorts to suit his position.
My take is Linda made a mistake when she initially said two weeks. Six months is the max time before a dmc review is considered late, 6 MONTHS. I think by end of March they have the data complete. From my limited experience with other stocks dmc reviews have been as long as 90 days plus or minus, average around 60 days, so it is taking a little longer than normal. I think there could be an issue or two that is taking longer to work out, but will hold, and wait.