Can you believe this tea pig??? Obama a war monger.?Hnest to god people.This donkey is the face of today's GOP. While Bushco ginned up the war in Iraq against domestic and universal international opposition magggottts like lackey blame Obama. Hey Lackey quick tell m the reason we attacked Iraq-- Any one of the three reasons Bushco tried to sell you will do you Fux news watching donkey
HEY tea pig. you phkstk donkey. Please keep it up. Your ignorance is priceless. You tea pigs are jusat so griffin schtoopid.
Origins: Anyone who has viewed Clint Eastwood's infamous "empty chair" monologue at the 2012 Republican National Convention likely has no illusions that the Academy Award-winning actor/director is a fan of President
Barack Obama. However, this circulated piece about the realizations of one's "twilight years" which ends with a castigation of the current president is not a reproduction of anything Clint Eastwood said or wrote.
In typical urban legend-like fashion, the earliest appearances of this item (from September and October 2013) are simply postings of untitled and uncredited e-mails that made no mention of Clint Eastwood; not until about three months later did versions identifying this piece as "Clint Eastwood's Twilight Years" begin to appear. (A representative for Eastwood also told us that he had nothing to do with this item.)
Hey taping you ignant phkstk. you donkey
Read more at http://www.snopes.com/politics/quotes/twilightyears.asp#74O6bZcFsAZ70rAk.9
FDA trial protocols have are not predicated on "scientific method" girl. They are predicated on statistics. Preventing a statistical confound and advancing science are two completely different concepts and are only loosely correlated.
I'm guessing you don't see the brutal irony in your post. Whoring for a hedge fund and betting against progress somehow makes you morally better than NWBO longs? At least they are on the side of patients if only for their own interest. Whoring for a hedge fund AND betting against patients may make you (according to your own std.) the worst person in the world.
I will bet 10k that the CONTROL group in th p3 lives longer than 14.7 months. Any takers ? We can set up an escrow with escrow instructions to pay the winner when the results come in. I also win if the trial is stopped for futility. You win if it is stopped for efficacy. Lemme know and I'll set up the escrow and wire instructions. If you are banking on 14.7 you are a fool. Stupp data is 2005 or 2007. Median OS with SOC is more like 18 mos today. Pretty much a fact. You could start checking by looking at IMUC's results in a 167 patient GBM trial. Lots of other sources out there as well
Funny stuff. The Horse's #$%$ gonna get info from the horses mouth. Hey donkey have a readIn the past,
FDA has approved manufacturing changes made DURING or after completion of clinical studies in situations where comparability data have provided assurance that the product would continue to be safe, pure, and potent (effective). Such manufacturing process changes, implemented before or after product approval, have included changes implemented during the expansion from pilot scale to full scale production, the move of production facilities from one legal entity to another legal entity, and the implementation of changes in different stages of the manufacturing process such as fermentation, purification, and FORMULATION. In each case, FDA reviewers have used their collective scientific and regulatory experience to provide the best evaluation consistent with the applicable regulatory scheme and current knowledge.
See donkey what you fail to understand is the most basic of differences. To wit: the difference between a BLA and an IND. You're such a moron you keep referring to an DC-'Vac as an IND. Well donkey this aint an IND it's a BLA. And the FDA's position on mfg changes in INDs and BLA's is verrrrry different. But I have enjoyed watching you make a foo of yourself.
to my point. It;s hard to read in this format but all the approved drugs here were for metastatic, advanced ,or relapsed cancers. Very different set of pups in the primary setting. And all of them had been previously approved fro other indications. These were just label expansion applications. Ask Donkey boy if he knows what label expansion trial are.
Drugs approves on the basis of PFS
Targeted Cancer Drug Approved (jurisdictions) Stage Type of Trial Increase in OS
Breast cancer Avastin (bevacizumab) US, Europe, Canada Metastatic III No
Breast cancer Ixempra (Ixabepilone) US, Canada Metastatic or locally advanced III No
Breast cancer Tykerb (Lapatinib ditosylalte) US, Europe, Canada Metastatic or locally advanced III No
Colorectal cancer Avastin (bevacizumab) US, Europe, Canada Metastatic III No
Colorectal cancer Vectibix (panitumumab) US, Europe, Canada Metastatic III No
Ovarian cancer Doxil (Doxorubicin) Europe, Canada Metastatic III No
Ovarian cancer Gemzar (gemcitabine) US, Europe, Canada Advanced III No
Ovarian Cancer Yondelis (trabectedin) Europe, Canada Relapsed III No
Renal Cell Cancer Nexavar (sorafenib) US, Europe, Canada Advanced III No
Renal Cell Cancer Votrient (pazopanib) US, Europe, Canada Advanced, metastatic III No
Renal Cell Cancer Sutent (sunitinib) US, Europe, Canada Advanced, metastic III No
NSCLC Tarceva (erlotinib) US, Europe, Canada Metastatic, locally advanced III Yes
Squamous Cell Cancer of Head and Neck Taxotere (docetaxel) US, Europe, Canada Inoperable, locally advanced III Yes
Its a big deal. To state the obvious, there is a difference between primary end[point and secondary endpoints.
PFS as an endpoint to support drug approval
Table 1 provides advantages and disadvantages of using PFS as an endpoint. PFS can reflect tumor growth and be assessed before the determination of a survival benefit. Its determination is not confounded by subsequent therapy. For a given sample size, the magnitude of effect on PFS can be larger than the effect on overall survival. However, the formal validation of PFS as a surrogate for survival for the many different malignancies that exist can be difficult. Data are USUALLY INSUFFICIENT to allow a robust evaluation of the correlation between effects on survival and PFS. Cancer trials are often small, and proven survival benefits of existing drugs are generally modest. The role of PFS as an endpoint to support licensing approval varies in different cancer settings. Whether an improvement in PFS represents a direct clinical benefit or a surrogate for clinical benefit depends on the MAGNITUDE of the effect and the risk-benefit of the new treatment compared to available therapies.
That being said I don't think there has ever been a FIRST line oncology therapy in a primary cancer application, approved on the basis of PFS. Feel free to do your own research
Rational minds can disagree with my choice of "virtually ensure" which is probably over the top. To my way of thinking, the PFS endpoint is coup de grace. I'll go out on a limb and say that NWBO will attempt to amend the endpoint to OS . If they do, they may or may not be successful, but even if they are, it will no doubt come with a substantial statistical penalty, which will raise the bar to approval. The interim look (s) will come with a statistical penalty irrespective of the endpoint.
In the aggregate I don't think most posters are giving the risk of another trial, enough weight. Approval could 7-10 years away (if ever). And a lot happens in 7 years. That said, like all junior biotechs, this is a news driven stock and in the near term there are several events that may be favorable for the stock, German reimbursement being first among them. I'd rather wait. The interim will provide some additional insight. Based on what I have seen from the results released so far form the"compassionate use" arm and DC Direct, I think the trial is unlikely to be stopped for safety but I doubt it will be stopped for efficacy either. My guess is that "continue the trial" will be seen as good news by the market. So the cheerleaders will crow and Michhone can wail.
Rather than clicking your heels together and saying there's no place like NWBO, perhaps you should start with the learning science, critically reviewing the results to date, a quick read of the the 7 functions of the dollar, identifying and understanding the various risks unrelated to the science, --timing, dilution, financing, etc., the differences between pharma and biotech, regarding scalability, gross margins etc, the patent portfolio paying particular attention to the difference between composition of matter patents and process patents. Then come back and make (perhaps slightly less) schttooooopid pie in the sky fantasies
It is this type of stupidididditty that determines the share price at the margin. At a minimum the company has gone on record as 30k-35k for the number so your "estimate" start off about 166% too high.
NWBO has almost 90mm share fully diluted so your 100 dollars should be closer to 60.
Ignoring the rest of the gibberish about patients and multiples etc. those two elementary mistakes change your revenue to 4.5B, your valuation to 27B and the share price (using current shares outstanding and ignoring future dilution) to about 300 bucks a share.
To make simple for the simple minded. UNless the results are stupendous, the FDA is unlikely to grant approval on the basis of this trial. The length of time, the change to mfg processes, the Amendments and a PFS endpoint virtually ensure that they will have to do another trial. So add in another three years and 100mm dollars to your spreadsheet Or in the case of the donkeys. your coloring book
Oh my little donkey. You are really precious. You might read the FDA's guidance to industry on the issue of manufacturing changes during a trial. Your effort as trying to save face is failing Your best course of action at this point would be shut your cockhole.. Also my little braying friend you have no idea what or how many process improvements have been made.
A method for preparing tumor lysate process is commonly called freeze/thaw. This is well known. The comparable DC process to my knowledge has no specific name. Calling it freeze thaw was as accurate a term as any without providing a complete explanation of the process. I am aware the processes are different but did not know the compete details. Nevertheless NWBO freezes DC's (and then thaws them) during the maturation process which was my point. Thx
That ain't the issue donkey NWQBO Cryopreserve DC's (and then thaws them) like I done told you. I think your response was "that would be stupid". How's that crow tasting?
You would be wise to pay attention to the bickering my guess is you don't really know much about the science. Less yet about clinical trials, risk reward calculation, the time value of money, SEC and FDA regs. etc
You may still make money because there are a few tidbits of good new that may come out before the results re in. E.g. A reimbursement agreement with German regulators. Perhaps -- the interim peek that will probably say continue the trial
NWBO has to use its 10 year old mfg process?? How would they do that? Cognate keeps an archaic outdated production line and and outdated process in order to conform to the trial protocol? You make me laugh quite a bit.
Make today the day you learn something donkey.
Just some help for the short bus crowd
Cryopreservation or cryoconservation is a process where cells, whole tissues, or any other substances susceptible to damage caused by chemical reactivity or time are preserved by cooling to sub-zero temperatures.
Well donk boy they do freeze DC's Yer looking more the fool every day. Thanks for doubling down on schtoopid. Here ya go Heeee -Haaaaw
.Activated, or partially matured, DC have been exposed to maturation agents, and have been arrested in the maturation process by cryopreservation