DEDUCED RECKONING: Northwest Biotherapeutics is finally ready for prime time [医药生物投资]

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[As of today, 12 Nov, a new article is published from the same author following up her previous article. you can read the new article at post #32 below]

[ 九楼有中文文章:树突状细胞免疫疗法用于脑瘤3期临床:患者生存期超10年]

[二十多年来投资过基本上所有金融产品,涉及大多数领域,包括股票,期货 等
投资正在发展中的医药生物公司是其中最具风险回报,也是最难的,最有意义的!]

The article below appeared in heraldtribune.com dated 14 October 2020:

Any cancer diagnosis is scary but nothing is more frightening than being told you have brain cancer. Glioblastoma (GBM) took U.S. Sens. John McCain and Ted Kennedy in very short order. The current standard of care was approved by the FDA in 2005 because it extended life by just two months.

It consists of resection (removal) of the tumor, radiation and chemotherapy, Merck’s Temodar (temozolomide, designed to shrink tumors). The Merck site for this drug warns you to ”wear rubber gloves, never touch it and never ever flush it down the toilet.” Possible side effects: nausea, vomiting … loss of balance, fainting, dizziness, hair loss … and seizures. Median survival is 15 months. Five-year survival is less than 6%.

Since 2005, more than 400 GBM trials have failed, some after promising Phase 2 studies. Northwest Bio undertook a completely different approach to this dread disease. Dr. Alton Boynton set out to harness the body’s own immune system to fight cancer. NWBO combines material from your own resected tumor with dendritic cells (withdrawn from your blood), which are then trained in the lab to recognize your tumor. Because the DCVAX-L that is ultimately returned to your body is your body’s own enhanced material it is not rejected as foreign. Therefore, there is no toxicity to this treatment. You might have redness at the site of the injection or a temporary headache, both addressed with acetaminophen. Either the drug works or it doesn’t.

In January 2019, the Sarasota Herald-Tribune got me a press pass to attend the Phacylitate Leaders World Conference in Miami. I believe I was the only analyst there when NWBO CEO Linda Powers gave a most astounding presentation. Read a summary on the company’s press page about all that has been learned about GBM over the 14 years under their lead scientist from UCLA, Dr. Linda Liau. Most stunning was the news that a single tumor could display more than 20,000 mutations of the original cancerous cells. Most of the chemo trials and other newer techniques have been aimed at designing a “silver bullet” that would kill the original cancer. That might gain you temporary remission but that drug becomes ineffective against the mutations. That would explain so many failed Phase 3 trials.

NWBO’s DC VAX-L is designed for the dendritic cells returned to your body to recognize both the tumor and its mutants. Because they are living cells, they can morph to combat the mutations as they come along and keep fighting your disease. While this trial was designed to investigate glioblastoma, the company believes it will work against all solid tumor cancers which are more than 80% of all cancers. Think of a body part that gets cancer and the drug can be made to fight it.

It is almost two years since I attended the Miami conference. I was not prepared to recommend it to you until now. I own it; Gramercy Capital and all of our clients own it. In recent weeks, NWBO has finally completed its Phase 3 trial. The data has been locked and sent off to the statisticians for evaluation.

Knowing that a lot of people who should be dead are not just alive but thriving, the trial was allowed to run for five years after the last patient was enrolled to gather complete data. Once the statisticians have analyzed the data, the study will be unblinded to the company and in turn to us.

Then a cascade of events will ensue: 1. The company will make a presentation at the Society of NeuroOncology on Nov. 20, at a main plenary session. 2. I anticipate that likely simultaneously an article will appear in a major medical journal of the importance of Cancer, Lancet, New England Journal or JAMA. 3. This stock will be relisted on a major stock exchange, perhaps even the NYSE making it easier for institutional investors to buy the stock. 4. This drug was “fast-tracked” in the UK in 2014 and I expect that a new drug application will be filed there very shortly after the results are known. 5. Applications will also be made in Germany, USA, and Canada. 6. UK approval could come in as few as three to five months after the filing pointing to approval as a 1H 2021 event.

Right now, NWBO is valued at less than $1 billion. If the trial is successful, and we will know quickly, this undervaluation will correct rapidly. Immunomedics was recently acquired for $21 billion by Gilead with a less promising drug. Like all biotech trials, this one can still fail. Do not spend more money than you can afford to lose but understand that this drug has the potential to alter all solid tumor cancer treatment for years to come.

Note to readers: Joan Lappin CFA will be speaking at the Money Show on Oct. 27 at 10:40 a.m. Free registration to the two-day event: Lappin.MoneyShow.com.

Joan Lappin CFA has been called an “investment guru” by Business Week and a “top manager” by the Wall Street Journal. The Sarasota resident founded Gramercy Capital Management, a registered investment adviser, in 1986. Email her at JLappincfa@gmail.com. Follow her on twitter: @joanlappin. Her past columns appear at heraldtribune.com/business/columns.
 
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The marching from oblivion to household name is just beginning! You will be seeing multiple price gap up before it flats out!

An old article:

Northwest Bio, Wow!

Bohsie Research

Long Only, Deep Value, Special Situations, Biotech


Summary
With Data Lock just announced, Top Line Date is imminent.
Numerous statistical and mathematical markers from available data shine a positive light on potential trial results.
The company may have a lucrative option even if median Overall Survival does not meet the secondary endpoints.
I have written about DCVax-L and Northwest Biotherapeutics in the past, crunching numbers, and statistically analyzing blinded data, and more so now I believe that even with the jump in share price, this undervalued stock has huge upside potential even in the worst scenario. With the blinded data we already have, and the last patient enrollment in November 2015, there is enough information already to show DCVax-L is a good investment. Here are my reasons:

1) We know that over 25% of the patients treated are showing a PFS greater than 15 months (and more likely 17 months +) (see my article) with the last enrollment occurring in November 2015, and the 248th PFS event occurring sometime between end of December 2016 and February 2017 (Article). With pseudo progressions being removed, even more so 15 months is unheard of, and no other trial has shown median PFS results over than 10 months. The Achilles heel of this trial is by no means the PFS Endpoint (mPFS), but rather the original secondary OS outcome (mOS) due mainly to the crossover.

2) This takes us to Overall Survivability. With the crossover, and with an effective vaccine, DCVax-L could actually ultimately hurt the trial itself by not meeting the 2 month increase in median Overall Survival. However, we know that the blinded mOS results are nearly two months greater than the blinded median OS results from the Optune trial, and over seven months greater than the SOC. And that is the blinded results. For the secondary outcomes to fail, the entire intent to treat population would need to show similar results to the treated Optune population. Additionally, there are shorts that try to add skepticism to these blinded results stating that all the intent to treat population used Optune treatments, resulting in the increased overall survival, however, as a statistician, this is statistically improbable, and secondly, the DCVax-L trial has been operating well before the Optune trial, years in fact. However, as I mentioned, if the vaccine is truly effective, then there is a chance that the two month increase will not be met, however, if that is the case, NWBO management will have a very strong case to compare these results to SOC populations, as recently approved by the FDA. I also wouldn't be surprised that NWBO rolled this comparison into their trial design when they recently received approval for their SAP (Statistical Analysis Plan). One area we do know that they are analyzing is with Methylated MGMY patients.


3) And that comes to my third point, Methylated and unMethylated MGMT patient data from blinded results show drastic increases in overall survival with increases of seven and nearly 10 months from blinded Optune results (see Statistically Significant article). If even one of these sub-population show drastic increases, these in itself will provide ample justification for approval of a vaccine that shows little if any side effects.

4) During the writing of this article, it was determined that not only was the SAP redefined in the EU, the primary endpoints of the study are now OS compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed gliobastoma. We already know that the blinded data shows much better results than control patients in every trial done to date, so this in itself is a huge positive assertion that there is a very good chance that the results will be positive. Additionally, a secondary endpoint is overall survival compared to contemporaneous clinical trials, in patients with recurrent GBM. I would even bet that this is similar to the SAP here in the U.S.

So after all this data and blinded information readily available, a redefined SAP that allows for comparison to contemporaneous trials, and even if the worse case scenario of the overall survival not meeting the two month increase, there is still enough positive outcomes from this trial that this would readily provide Linda Powers and her board ample bargaining power to sell NWBO's proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range, providing a share price of between $14 and $28 per share. Even if Big Pharma kept their wallets tight, a buyout of $5 billion would readily attract one company that feels like they are trailing the immunotherapy curve.

Of course, as is the issue with all stocks, risk plays a significant role, and this should always be taken into account when investing. However, as I have said many times, this stock has significant upside potential, even after the stock recent surge near the $1 range, it has the potential to skyrocket ten to twenty fold or more with positive results. I liken this stock to buying a lottery ticket with much better odds then one would ever get. However, one does not buy a lottery ticket without the understanding that it is not a given, and money may be lost, but the upside may be huge. At a share price hovering under $1, and the top line data expected any week, or even day now, this is readily an investment worth the risk, as the payoff may have you saying, Northwest Bio, WOW!


Disclosure: I am/we are long NWBO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: As with all stocks, there are risks associated with this recommendation, so understanding these risks and doing your own due diligence is necessary prior to investing.
Editor's Note: This article covers one or more microcap stocks. Please be aware of the risks associated with these stocks.
 

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想想每一剂治疗性抗癌疫苗都是量身定做, 它无毒性,无副作用。并且根据原理 (MOA, mechanism of action),这种疫苗可以用于治疗所有十五种固态癌症。如果成功,将会对人类做出多大的贡献!

那么,为什么要量身定做呢?因为每一个病人的恶性肿瘤都是独特的,而且有很多变异, 比如一个单一的恶性肿瘤可能有多达两万多的变异,理论上所有非量身定做的治疗方法都不可能有效。

这种疫苗的名字就叫DCVax, 是由Northwest Bio (NWBO) 开发的.

根据已知数据,用这种疫苗治疗的恶性脑瘤病人五年以上的存活率为大约20%, 而现今标准治疗的病人五年以上的存活率为大约5%。最终结果将很快公布!
 
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DCVax is an investigational personalized immunotherapy being developed by Northwest Biotherapeutics to treat patients with solid tumors.
The DCVax technology includes several product lines: DCVax-L for patients with solid tumors that are resectable (can be surgically removed), DCVax-Direct for patients with unresectable tumors, and DCVax-Prostate designed specifically for prostate cancer patients.
The technology (DCVax-L) is in one ongoing and advanced clinical trial; two other planned studies have not begun enrolling patients and their status is unclear.
How DCVax works
DCVax uses a patient’s own immune cells to fight cancer. In contrast to other immunotherapies that train T-cells to attack a single target on cancer cells, DCVax uses different types of immune cells to recognize different targets. In addition, DCVax engages more than just immune cells; it also mobilizes signaling molecules (such as cytokines) with the aim of involving the entire immune system.
All DCVax products use the patient’s immune cells to create a vaccine that boosts the immune system’s response to cancer cells, but there are differences in the way they are made and how they are given to the patient.
DCVax-L
DCVax-L, for use in patients with solid and removable tumors, is made by collecting immune cells called monocytes from a patient’s blood. Thes monocytes are then grown in the laboratory to mature into dendritic cells, master immune cells that activate and coordinate immune responses.
As the dendritic cells mature they are “educated” to recognize biomarkers, or proteins specifically associated with the patient’s tumor, which are harvested from cancer cells collected from the patient’s tumor during surgery.
The mature, “educated” dendritic cells are then injected back into the patient. Once in the bloodstream, the “educated” dendritic cells recruit other immune cells and “teach” them to attack cancer cells. Because the activated, these “educated” immune cells multiply by themselves inside the body, with the intent of allowing small doses to yield a large and long-lasting response.
DCVax-L in clinical trials
DCVax-L is currently being tested in in patients with metastatic ovarian cancer and glioblastoma multiforme (GBM, one of the deadliest forms of brain cancer).
A Phase 3 trial (NCT00045968) to evaluate the effect of DCVax-L on disease progression and survival in adult patients with newly diagnosed GBM began in 2006 and is close to completion. For the trial, 331 participants have been randomized to receive up to 10 treatments, two injections per treatment, of either DCVax-L or placebo for up to 10 years. The multicenter trial has over 50 sites across the U.S., the UK, and Germany, but is no longer recruiting participants.
On Feb. 6, 2017, Northwest Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) had lifted a partial clinical hold placed on the Phase 3 trial. A partial clinical hold is a delay or suspension of some aspects of a trial to provide time to the FDA to gather or review additional information or data. The lifting allowed the trial to continue, although a final 17 patients were not enrolled and the study is continuing with 331 participants. The company announced in September that independent analysis of trial data showed “encouraging projections” of median overall survival and progression free survival.
A previous Phase 1/2 trial of DCVax-L in patients with new or returned GBM reported that DCVax-L, when given alongside standard of care treatment, increased progression-free survival and overall survival beyond what is expected with standard of care alone.
A Phase 1 trial (NCT00683241) tested the safety and feasibility of using DCVax-L, combined with Avastin (bevacizumab) and cyclophosphamide, to treat about 36 women with recurrent epithelial ovarian cancer or primary peritoneal cancer. The trial assessed how the immune system responded to the vaccine.
DCVax-Direct
DCVax-Direct also collects monocytes from the patient’s blood, but these are not fully matured into dendritic cells in the laboratory. Instead, they are injected directly into the tumor inside the body, and are designed to encounter the cancer biomarkers and mature into “educated” dendritic cells that “educate” and activate the rest of the immune system to fight cancer cells.
DCVax-Direct in clinical trials
A Phase 1/2 clinical trial (NCT01882946) was initiated, and aimed to enroll about 60 patients with unresectable solid tumors, including liver, colorectal, pancreatic, and skin (melanoma) cancers. Its stated purpose is to evaluate the safety of DCVax-Direct, how the tumor responds to treatment, and how long patients survive with and without tumor progression. The status of this trial, however, is not clear or known.
DCVax-Prostate
DCVax-Prostate is designed to treat patients with late-stage prostate cancer that is not treatable with hormones. Because this type of cancer has spread beyond the prostate, there is no distinct tumor, cancer cells that can be harvested to make DCVax and DCVax cannot be injected directly into the tumor. To make DCVax-Prostate, prostate-specific membrane antigen (PSMA), a protein found in almost all advanced prostate cancers, is produced in the laboratory and used to “educate” the patient’s dendritic cells.
DCVax-Prostate in clinical trials
A randomized Phase 3 clinical trial (NCT00043212) is intended to test the safety and effectiveness of DCVax-Prostate in men with hormone-refractory prostate cancer (cancer that does not respond to hormone treatment). The trial was cleared by the FDA, but withdrawn prior to enrollment and is not active. Northwest Biotherapeutics states on its website that it is looking to partner with another company to proceed with this trial.
Additional information
The company reports that, to date,no patient treated with DCVax has experienced any serious adverse events.
***
Immuno-oncology News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.








Helen Parker Atkinson
 

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树突状细胞免疫疗法用于脑瘤3期临床:患者生存期超10年

来源: 新浪医药新闻  2018-11-21 A- A+



Northwest Biotherapeutics(NWBio)是一家临床阶段的生物技术公司,专注于开发基于树突状细胞的DCVax®个体化免疫疗法,用于实体瘤的治疗。近日,该公司在美国新奥尔良举行的2018年美国神经肿瘤学会(SNO)第23届年会上公布了先导疗法DCVax-L治疗新诊多形性胶质母细胞瘤(GBM)的III期临床研究的更新设盲中期数据*。
1602883934927.png

该研究是一项随机、双盲、安慰剂对照研究(NCT00045968),始于2007年,在美国、加拿大、德国、英国超过80个医疗中心开展,评估了DCVax-L联合标准护理(SOC)治疗新诊GBM的疗效和安全性。该研究共入组了331例患者(即“意向性治疗[ITT]群体”),最后一批患者入组是在2015年11月。所有患者在入组研究前已接受手术切除并接受了6周SOC放化疗。研究中,患者以2:1的比例被随机分配接受SOC+DCVax-L(n=232)或SOC+安慰剂(n=99)。该研究将外周血单个核细胞(PBMC)用作安慰剂,因为这类细胞在视觉上与DC很难区分,并且被认为是免疫不活跃的。
研究中,两个治疗组继续接受每月一次替莫唑胺辅助化疗(150-200mg/m2/天×5天,每28天为一个疗程),同时接受DCVax-L或安慰剂治疗(第0、10、20天治疗,随后是第2、4、8个月治疗,此后从第12个月开始每个6个月治疗一次)。每次DCVax-L治疗涉及250万个DCVax-L,在上臂皮内注射,左右手交替。治疗期间,若肿瘤进展或复发,患者可被允许接受DCVax-L治疗。在2017年中期数据收集时,所有患者通过了1年时间点,并且大多数患者通过了2年时间点。从2017年3月到2018年10月,数据的进一步成熟为更多的患者提供了达到更晚时间点(3年或更久)的机会,并使得生存曲线的“长尾(long tail)”得以更加清晰的展现。长尾是免疫治疗的一个关键焦点。
TOP100例患者
该研究中前100例患者(存活时间最长的患者)可被看成是生存长尾的一个量度。来自这些患者中期总生存期(OS)数据的Kaplan-Meier(KM)生存分析结果如下:
1602883979060.png

前100例患者的生存似乎并没有完全由已知的预后因素来解释。例如,这100例患者中只有8例患者在合并3个关键预后因素(年龄<50岁,甲基化的MGMT基因状态、肿瘤完全切除)方面处于有利地位。该研究中,前100例患者的人口统计学比全部331例ITT患者的人口统计学稍微有利,且包括了更多的甲基化MGMT患者。
总的ITT群体(全部331例)
到目前为止,所有入组研究的患者中已有90%接受了DCVax-L治疗,这是由于研究设计中内设的交叉选择。对ITT群体不同时间点OS中期数据的KM生存分析结果如下:
1602884015248.png

在这项III期研究中,ITT患者的人口统计学与其他胶质母细胞瘤III期临床研究中的ITT患者具有可比性,并且这些患者与其他临床研究中的患者在同一阶段入组(6周SOC放化疗之后)。
MGMT状态
目前,“手术—替莫唑胺同步放化疗—替莫唑胺辅助化疗”是国际上公认的新诊恶性脑胶质细胞瘤的SOC。而MGMT基因启动子是否甲基化(有利)或非甲基化(不利)是影响接受SOC患者生存的关键因素,会影响其对替莫唑胺化疗的敏感性。根据MGMT甲基化状态的患者生存中期数据的KM生存分析结果如下所示:
1602884059690.png

针对上述数据,NWBio首席执行官Powers女士评论称,“我们很高兴看到这些数据是如何成熟的,同时也要感谢我们的科学顾问委员会,是他们强烈建议不要过早对研究揭盲。如果过早揭盲,就会失去观察到患者更大程度生存的机会,也就永远不知道其生存潜力。在达到数据锁定之前,该研究的数据将继续成熟。此外,由于中期数据是设盲合并数据,我们目前还不知道治疗组和对照组的明确分界。但我们认为,尽管有充分的理由允许数据进一步成熟,公司现在应该继续推进完成该研究项目所需的几个阶段的工作,包括最终确定统计分析计划、进行最终的数据收集、数据验证和数据锁定,然后对数据进行揭盲和分析。”
1602884103265.png

之前,NWBio公司已完成了两项I/II期研究,共入组了39例患者,其中20例新诊GBM,19例复发性GBM及其他胶质瘤患者。结果显示,接受DCVax-L和SOC治疗的新诊患者,肿瘤无复发中位时间约为2年(超出SOC的3倍),中位生存时间约为3年(超出SOC的2倍)。
而此次III期研究中,有相当一部分接受DCVax-L治疗的患者具有更长的生存期。截至2011年7月的长期数据更新时,33%的患者生存时间达到或超过4年27%的患者生存时间达到或超过6年。截止2018年,I/II期研究中有2例患者生存时间已经超过10年,而相比之下,当前SOC的中位生存时间仅为14.6个月。
树突状细胞个体化免疫疗法:调动免疫系统靶向肿瘤所有抗原
DCVax(树突疫苗)
是一种使用活化树突细胞[免疫系统的主细胞(master cell)]的平台技术,旨在激活和引导免疫系统攻击癌细胞。常规的抗癌药,使用一种活性制剂攻击肿瘤的一个靶标,而DCVax则是使用多种活性剂攻击肿瘤的多个靶点。NWBio公司认为,DCVax技术的至少3个关键方面促成了迄今为止临床研究中的积极结果:1)被设计为动员整个免疫系统,而不只是免疫系统中众多免疫成员的某一类;2)所针对的靶标并非某一个,而是患者肿瘤的全套生物标记物;3)是个体化的,靶向患者肿瘤上表达的特定生物标志物。
DCVax技术有望应用于大多数癌症。目前,NWBio已开发出了两类产品:DCVax-L(针对可手术切除的所有实体瘤,皮下注射)和DCVax-Direct(针对不能手术切除的所有实体瘤,直接注射入肿瘤内)。
1602884145110.png

NWBio公司管线资产(来自Northwest Biotherapeutics官网)
DCVax-L是一种个体化的树突状细胞免疫疗法,其治疗流程为:1)从患者血液中分离出“单核细胞(树突状细胞前体)”,进行体外培养并将其分化为树突状细胞;2)制备患者自身肿瘤组织裂解物,将其呈递给前述的树突状细胞来识别肿瘤特异性抗原;3)装载肿瘤特异性抗原的活化树突状细胞被高度提纯,成为个体化的DCVax-L,并通过上臂皮下注射进入患者体内;4)这些DCVax-L树突状细胞将肿瘤特异性抗原呈递给体内的免疫系统(T细胞,B细胞和其他免疫细胞),下达消灭指令,让体内的免疫细胞找到带有这种特异性抗原的癌细胞然后清除。
重要的是,每一个激活的、装载肿瘤特异性抗原的树突状细胞都具有很大的乘数效应(multiplier effect),可动员数百个T细胞和其他免疫细胞。因此,小剂量的此类树突状细胞就可以动员大规模、持久的免疫应答。同样重要的是,DCVax-L是无毒的。在迄今为止的临床研究中,长达10多年和超过1000个疗程的治疗中没有出现任何诸如化疗涉及的毒性,也没有发生治疗相关的严重不良事件。
DCVax-L目前正开发用于GBM,这是最常见也是最致命类型的原发性脑肿瘤。该病当前标准护理包括手术、放疗和化疗,从手术切除到复发的中位时间仅为6.9个月,中位生存期仅为14.9个月。在过去30年来,GBM患者的临床结局几乎没有改善。近年来,GBM发病率呈上升趋势,原因不明,迫切需要新的和更好的治疗方法。
*自2017年3月中期数据收集以来,截止2018年10月,更新数据继续成熟,并表现出了鼓舞人心的患者生存。目前,该研究仍然保持设盲,所有中期数据均基于设盲的基础上(合并治疗组和对照组数据)。(新浪医药编译/newborn)
文章参考来源:
1、Updated Interim Data from Phase 3 Trial of DCVax?-L for Glioblastoma
2、Pipeline - Northwest Biotherapeutics
3、First results on survival from a large Phase3 clinical trial of an autologous dendritic cellvaccine in newly diagnosed glioblastoma


*声明:本文由入驻新浪医药新闻作者撰写,观点仅代表作者本人,不代表新浪医药新闻立场。
 
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Looks like another mini-gap up day today -- new multi-year high, and Topline data has yet to be announced:

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The recent sharp share price rise is the result of the market which has continually gained confidence that the underlining trial will be successful of which topline data is about to release any day now, after digesting the newly updated FDA guideline Demonstrating Substantial Evidence of Effectiveness for Drugs, and newly found endpoint change in EU clinicaltrial register, which fits well with new FDA guideline.
 
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