Jake it would be nice if it was indeed proof. The reason it is not proof is NOT ONE person knows if the DMC has TOLD the fda anything at all regarding results of the interim analysis other than SAFETY.
IF nwbo does not have the info rest assured the FDA does not either. THE DMC works for NWBO not the FDA, though they do have an obligation to the FDA to report SAFETY issues.
Seems every one or near EVERY one thinks the DMC is a branch of the FDA.
If the FDA has the data then if asked for we can figure it gets shared. I doubt at this point the FDA has the data, I think NWBO would get the data before the FDA. The DMC is not a government agency, BUT a private company. They are obligated to report to the FDA if they feel a drug is harmful, they must report this same data to the company. IF NWBO does not have the info I do not believe anyone else does.
Reread what I wrote, these hospitals applied for the exemption quite a while ago WAY before all the 66 events took place. WELL, that is my understanding right or wrong, it is how I read things. NWBO applied for this quite a while ago, several other companies have applied also. There are TWO hospitals for alternate medicine in Germany that USE unapproved dendritic technology, I think this exemption was highly anticipated by the 6 hospitals because of that.
I agree, I do not believe they SAW ANY phase three data. This review by the German government started months ago, they did look at ALL of NWBO studies, data from prostate studies, phase 1-2 brain even the animal studies. This RULING opens up treatment for ALL types of brain tumors not JUST gbm which is a big win for nwbo.
Making this RULING for them though a first, might have been far easier than here because of reported successes at medical center cologne using a similar dcvax for cancers and reported cures. Though Gorter at Cologne has been called a quack by some for using unproven alternate medicines, patients that have survived using that version of dcvax might be known to regulators. Keep in mind some of these HOSPITALS that never saw the phase 3 data anticipated this approval with EARLY applications. I point to Medical Center Cologne and patient survival there as reason for the early applications. Or is it believed THESE hospitals had ACCESS to this blinded phase 3 too. IT IS WISHFUL thinking to think the pei saw phase 3 data, but truth is, the hospitals expected this ruling all along.
DCVAX is a might win if cured, and has no side affects if not cured benefit. The fact the national health insurance will pay is the BIGGEST vote of confidence in NWBO early studies. That said do any of us know if the insurance aspect is not going to be PART of any such ruling??? My guess is that they go hand in hand.
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.