Reading Milestones Level 2 Blue Complete Program Design

Reading Milestones Level 2 Blue Complete Program Design

Find the latest business news on Wall Street, jobs and the economy, the housing market, personal finance and money investments and much more on ABC News. Biotech selloff leaves Wall Street disillusioned. After 5 years of a raging bull market, more than 1. IPOs and tens of billions in proceeds, there is a debate on whether the violent selloff in biotech stocks is a hiccup or the beginning of a real correction. Reading Milestones Level 2 Blue Complete Program Design' title='Reading Milestones Level 2 Blue Complete Program Design' />InformationWeek. News, analysis and research for business technology professionals, plus peertopeer knowledge sharing. Engage with our community. The Compliance Store Complete webbased healthcare compliance info. Information and resources about the new academic content standards for English language arts and mathematics adopted by the State Board of Education on August 2, 2010. After 5 years of a raging bull market, more than 140 IPOs and tens of billions in proceeds, there is a debate on whether the violent selloff in biotech stocks is a. Believe it or not, there was once a time when computers took up entire rooms. As you sit there, appreciating your svelte desktop, check out our complete history of. Programs, majors and courses on offer at The University of Queensland. I have no idea where the sector is heading in the coming weeks but it seems like the overall sobering experience coupled with this months selloff changed Wall Streets perception around biotech. Investors are finally realizing drug development is fraught with uncertainty and that biotech is an attractive but not infallible segment, which is why I expect the correction to continue in 2. Biotech valuations are still rich and factor in limited risk e. Even after a 1. 5 2. This is dramatically better than the 6. NASDAQ over the same period. Such outperformance is justifiable to some extent by real progress, sometimes true breakthroughs HCV, immuno oncology, gene therapy etc. This valuation gap isnt new, however, for the first time it is accompanied by a fundamental change in sentiment around biotech as a sector. To me, this is an important warning sign because of all sectors, biotech probably has the highest dependency on sentiment rather than hard numbers. A Letter to the Community. The year 2016 has been one of the most significant in the 150year history of Reading Health System. In 2016, we reached major milestones. I/41FkW3oAq4L._SR600%2C315_PIWhiteStrip%2CBottomLeft%2C0%2C35_PIStarRatingFOURANDHALF%2CBottomLeft%2C360%2C-6_SR600%2C315_ZA(10%20Reviews)%2C445%2C286%2C400%2C400%2Carial%2C12%2C4%2C0%2C0%2C5_SCLZZZZZZZ_.jpg' alt='Reading Milestones Level 2 Blue Complete Program Design' title='Reading Milestones Level 2 Blue Complete Program Design' />The wave of biotech IPOs in 2. Biotechs have a dream factor very few other sectors do and this enabled companies to raise huge amounts of money in IPO proceeds at high valuations, sometimes with limited or no clinical data. Initially, biotech IPOs were perceived as a huge success story, cementing biotechs position as Wall Streets favorite sector. But in the second half of 2. Despite some phenomenal exits like Receptos and ZS Pharma, most biotech IPOs now have negative returns and even stars like Agios AGIO, Bluebird BLUE and Sage SAGE gave back most of their gains. IPOs and overall proceeds but the performance of class of 2. Traumatic experience with DMD stocks. Last month I wrote about how hematology stocks were punished after failing to meet unrealistic expectations. The same is true for DMD stocks Biomarin BMRN, Sarepta SRPT and PTC Therapeutics PTCT but in this case the exaggerated expectations relied on shaky fundamentals to begin with. It is hard to believe that at some point in 2. B to these programs despite various issues and uncertainties which were known at the time. The desperate need for new DMD drugs coupled with a permissive regulatory environment enabled DMD companies to sell their drugs as breakthrough treatments for a devastating disease with a high likelihood of approval. In retrospect, all three drugs had very weak clinical packages but this didnt bother investors who relied more on wishful thinking and incomplete, vague disclosures rather than clinical evidence. Biomarins drisapersen, which came by way of the 2. Prosensa, was the first to fall. Biomarin acquired Prosensa after drisapersens P3 failure, which was blamed on trial design issues. Biomarin convinced investors that there was enough evidence in the failed P3 based on subset analyses and smaller P2 studies to get the drug approved based on the totality of the data. Another term people often used to describe the drug was approvable as opposed to effective or proven. The support Biomarin got was almost religious as investors relied on the companys successful track record they know what theyre doing in the field of rare diseases while ignoring obvious questions see one example from Adam Feuerstein. FDAs review of the drisapersen package was brutal. Vag-Com 311 Windows 7 on this page. As part of an advisory panel last November, FDA reviewers easily tore apart every claim and data mining presented by Biomarin, who probably relied too much on anecdotal testimonials of patients and their families. The panel voted overwhelmingly against the drug and last week a formal complete response letter followed. Sarepta is about to receive a similar treatment from the FDA based on briefing documents released last week see Feuersteins review. The companys DMD drug eteplirsen is a direct competitor to Biomarins drisapersen but in contrast to Biomarin, Sarepta would like the FDA to approve eteplirsen primarily based on a 1. Until last week, eteplirsen was perceived as better positioned because functional improvement 6 minute walk test, 6. MWD was accompanied by increased dystrophin levels in muscles this was not observed with drisapersen and fewer side effects. But FDAs analysis revealed many issues making the data set inconclusive on top of being very limited. It turns out that after 3 years of treatment, dystrophin levels reached only 0. Eteplirsens FDA panel is taking place this Friday. PTC submitted ataluren Translarna for FDA approval earlier this month. Ataluren, intended for a different subset of DMD patients caused by nonsense mutations, also failed to demonstrate a clinical benefit in a large P3. Nevertheless, the company would like to approve the drug in a subset of patients with baseline 6. MWD of 3. 00 4. 00 meters where a statistically significant effect was observed. This subset represents less than half of the patients in the study and PTC claims this subset analysis was prospectively defined with the FDA. Lets see how the FDA describes itAtalurens P3 was designed based on subset analyses of a prior failed P2. PTC looked for patients in which ataluren demonstrated clinical benefit and applied these criteria in P3. After seeing the P3 data, the company now asks the FDA to rely on a new subset analysis. This casts serious doubt on the entire study and it remains to be seen whether this analysis stands up to scrutiny. Biotechs still offers tremendous value proposition. It is important to make the distinction between biotech companies and their stocks. Most high profile biotechs are decent companies with a solid scientific foundation and as a group they continue to make progress regardless of stock performance. As was the case with other technological leaps, I am sure biotech will eventually deliver, it will simply take more time and actual reward may be significant but more modest than initial expectations. Fundamentally, things have never been better for the drug development industry which now has both the development tools and financial resources to advance the field. With that in mind, I plan to keep my short positions BIS which consists  2. I still intend to be selective and have positions in companies with solid clinical data and depressed valuations as they are likely acquisition targets. Names I like include companies with clear clinical Po. C in P2s like Esperion ESPR and Trevena TRVN as well as companies with positive P3 data with a relatively high likelihood of regulatory approval such as Exelixis EXEL and Amicus FOLD. Portfolio holdings Jan 1. Strategic Defense Initiative Wikipedia. The Strategic Defense Initiative SDI was a proposed missile defense system intended to protect the United States from attack by ballistic strategic nuclear weapons intercontinental ballistic missiles and submarine launched ballistic missiles. The system, which was to combine ground based units and orbital deployment platforms, was first publicly announced by President Ronald Reagan on 2. March 1. 98. 3. 1 The Strategic Defense Initiative Organization SDIO was set up in 1. United States Department of Defense to oversee the Strategic Defense Initiative. Reagan was a vocal critic of the doctrine of mutual assured destruction MAD, which he described a suicide pact. In his 1. 98. 3 speech, he called upon the scientists and engineers of the United States to develop a system that would render nuclear weapons obsolete. SDI was an important part of his defense policy, intended to end MAD as a nuclear deterrence strategy. A wide array of advanced weapon concepts, including lasers,23particle beam weapons and ground and space based missile systems were studied, along with various sensor, command and control, and high performance computer systems that would be needed to control a system consisting of hundreds of combat centers and satellites spanning the entire globe. A number of these concepts were tested through the late 1. The ambitious initiative was criticized for allegedly threatening to destabilize the MAD approach and to possibly re ignite an offensive arms race. SDI was nicknamed largely in the mainstream media as Star Wars, after the popular 1. George Lucas. In 1. American Physical Society concluded that a global shield such as Star Wars was not directly feasible for operational status using existing technology, and that about ten more years of research was needed to know whether such a system was possible. After the publication of the APS report, SDIs budget was repeatedly cut. By the late 1. 98. Brilliant Pebbles concept, which was expected to be much less expensive to develop and deploy. By the early 1. 99. Cold War ending and nuclear arsenals being rapidly reduced, political support for SDI collapsed. SDI officially ended in 1. President Bill Clinton redirected the efforts towards theatre ballistic missiles and renamed the agency as the Ballistic Missile Defense Organization BMDO. BMDO was renamed to the Missile Defense Agency in 2. This article covers defense efforts under the SDIO. HistoryeditNational BMDeditThe US Army had considered the issue of ballistic missile defense BMD as early as late in World War II, but a series of studies on the topic suggested attacking a V 2 rocket would be difficult simply because the flight time was so short that it would leave little time to forward information through command and control networks. Bell Labs pointed out that although longer range missiles flew much faster, their longer flight times would address the timing issue and their very high altitudes would make long range detection easier. This led to a series of projects including Nike Zeus, Nike X, Sentinel and ultimately the Safeguard Program, all aimed at deploying a nationwide defensive system against attacks by Soviet ICBMs. The reason for so many programs was the rapidly changing strategic threat the Soviets claimed to be producing missiles like sausages, and ever more missiles would be needed to defend against this growing fleet. Adding radar decoys and additional warheads to existing missiles allowed the offensive force to grow both more rapidly and much more cheaply than the defense. An early estimate suggested one would have to spend 2. Soviets spent on offense. The addition of MIRV in the late 1. When initially faced with this realization, President Eisenhower asked ARPA to consider alternative concepts. Their Project Defender studied all sorts of systems, before abandoning most of them to concentrate on Project BAMBI. BAMBI used a series of satellites carrying interceptor missiles that would attack the Soviet ICBMs shortly after launch. This boost phase intercept rendered MIRV impotent a successful attack would destroy all of the warheads. Unfortunately, the operational cost of such a system would be enormous, and the US Air Force continually rejected such concepts. Development was cancelled in 1. Through this period, the entire topic of BMD became increasingly controversial. Early deployment plans were met with little interest, but by the late 1. Sentinel system were met by thousands of angry protesters. After thirty years of effort, only one such system would become operational a single base of the original Safeguard system became operational in April 1. February 1. 97. 6. Precursor to SDIeditGeorge Shultz, Secretary of State under Reagan, suggests that a 1. Edward Teller the so called father of the hydrogen bomb was an important precursor to SDI. In the lecture Teller talked about the idea of defending against nuclear missiles by using nuclear weapons. Held at Lawrence Livermore National Laboratory, the lecture was attended by Reagan shortly after he became the governor of California. In 1. 97. 9, Ronald Reagan visited the NORAD command base, Cheyenne Mountain Complex, where he was first introduced to the extensive tracking and detection systems extending throughout the world and into space. However, he was struck by their comments that while they could track the attack down to the individual targets, there was nothing one could do to stop it. Reagan felt that in the event of an attack this would place the president in a terrible position, having to choose between immediate counterattack or attempting to absorb the attack and then maintain an upper hand in the post attack era. Shultz suggests that this feeling of helplessness, coupled with the defensive ideas proposed by Teller a decade earlier, combined to form the impetus of the SDI. In the fall of 1. Reagans request, Lieutenant General Daniel O. Graham, the former head of the DIA, briefed Reagan on a concept he called the High Frontier, a missile shield composed of multi layered ground and space based weapons that could track, intercept, and destroy ballistic missiles, which would theoretically be possible because of emerging technologies. It was designed to replace the MAD doctrine that Reagan and his aides described as a suicide pact. In September 1. 98. Graham formed a small, Virginia based think tank called High Frontier to continue research on the missile shield. The Heritage Foundation provided High Frontier with space to conduct research, and Graham published a 1. High Frontier A New National Strategy that examined in greater detail how the system would function. The initial focus of the strategic defense initiative was a nuclear explosion powered X ray laser designed at Lawrence Livermore National Laboratory by a scientist named Peter L. Hagelstein1. 6 who worked with a team called O Group, doing much of the work in the late 1. O Group was headed by physicist Lowell Wood, a protg and friend of Edward Teller. Ronald Reagan, relying on Grahams report and news of Hagelsteins breakthrough in 1. March 2. 3, 1. 98. Star Wars speech. Reagan announced, I call upon the scientific community who gave us nuclear weapons to turn their great talents to the cause of mankind and world peace to give us the means of rendering these nuclear weapons impotent and obsolete. This speech, along with Reagans Evil Empire speech on March 8, 1. Florida, ushered in the final major escalation in rhetoric of the Cold War prior to a thawing of relations in the mid to late 1. The concept for the space based portion was to use lasers to shoot down incoming Sovietintercontinental ballistic missiles ICBMs armed with nuclear warheads. Nobel Prize winning physicist Hans Bethe went to Livermore in February 1.

Reading Milestones Level 2 Blue Complete Program Design
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