Farmas USA

CEO de ARWR compra 16k cromos
http://www.sec.gov/Archives/edgar/data/879407/000118143114034318/xslF345X03/rrd417662.xml

En la lista que sigo, lo que vi ayer fue una plaga de reversals, sobre todo en el sector oil-gas.

quizas no sea el tema
alguien trabaja con alguna plataforma de FOREX?????
Gracias

Yo hice algún pinito con la de IB.

Termino de ver como tapaban con ladrillos 4 portales de una finca terminada, donde cojones esta la recuperación económica, el ibex real no llega a 8000, pero el mercado es soberano y va por libre. Seguimos desahuciando ancianas de 80 años con convaleciente de cancer a la espera de una operación de cadera y que tenia una casa social del ayuntamiento de Madrid que vendió a los fondos buitre. Dan ganas de vomitar.

ACTC

Rueda de prensa sin preguntas. Lo importante:

Phase II SMD (100 patients) will start 4th Quarter of this year or EOY, it will take 18-24 months to complete and taking place in 30 sites across North America and United Kingdom

Phase II AMD (50 Patients) will start 1st Half of 2015 and expected to be completed in the middle of 2016 and taking place across 10 Trials Sites across North America.

Artículo bullish en SA de ayer noche, que está bien, pero que no va a hacer subir la acción. El sentimiento es negativo, hasta 2016 no va a haber resultados y nos espera la dilución. Yo probablemente vuelva a abrir corto hoy:

http://seekingalpha.com/article/2564665-advanced-cell-technology-has-groundbreaking-results

No obstante, hay que estar atentos a la subida al Nasdaq y al anuncio del estudio de fase II; en ambos casos tendrá que tirar algo para arriba. Si entran institucionales, igual se mantiene; si no, será carne de corto otra vez.

Copio las partes interesantes de la rueda de prensa:

The primary purpose of today's call is to discuss the positive results of our Phase I/II studies. They were published on line yesterday evening in the Lancet, a leading peer-review medical journal. I'm going to let Bob and Eddy discuss the results and our plans for the Phase II trials in detail, but I first wanted to stress the importance of the data to our patients, our investigators and to our company and shareholders. Overall, results of the studies demonstrated long-term safety in patients using our proprietary retinal pigment epithelium, or RPE cells, for the treatment of Stargardt's macular degeneration, or SMD, and dry age-related macular degeneration, or AMD, as we had hoped for. The publication includes data from the 18 US-based patients who had reached the six-month anniversary of their treatment at the time this study was submitted for publication. In fact, the median follow-up period for the 18 patients was close to 22 months, and this gives us added confidence in the safety profile that we've seen. We were also very pleased to see evidence of biological activity of the RPE cells, with the added benefit of signs of visual improvement in many patients, even though the study was not designed specifically to show this. This is very encouraging as we move into the Phase II studies. These positive results also represent an important milestone for the company as we transition ACT from a technology platform company into a productive development company. The data also reinforces and strengthens our leadership position in regenerative ophthalmology. To patients, these results indicate that transplantation of differentiated RPE cells derived from human embryonic stem cells, or HESCs, as starting point could provide a potentially safe new source of cells for the treatment of a variety of unmet medical conditions such as SMD and AMD. Furthermore, this is the first time that medium to long-term safety has ever been shown for this type of technology in individuals with evident disease, which puts us at the forefront in this exciting area of regenerative medicine. We have also had helpful dialogue with the FDA and other regulatory bodies, which has informed our prior development planning going forward. Before I turn the call over to Bob Lanza, I want to highlight the market characteristics underlying these programs. AMD is a significant market opportunity and a large unmet need exists for novel treatment that could potentially change the way the disease is treated. Currently there is no effective treatment for dry AMD, and there are more than 30 million patients in the US and Europe suffering from AMD, with dry AMD accounting for 80 to 90% of this number. SMD, a juvenile form of macular degeneration, is designated as an orphan indication that has a devastating impact by robbing younger patients of their vision, and there is no effective treatment available for this disease. Clearly, we have a unique opportunity here to make a difference in many people's lives in the future, and we are committed to making this happen. I will now turn the call over to Bob Lanza to review the data.

Bob Lanza: Thank you Paul. I first want to echo Paul's comments about how important and exciting these data are to our patients, investigators and to Advanced Cell Technology. I would also like to thank the patients for their willingness to participate in these safety studies. As I have said on previous calls, diseases affecting the eye are attractive first-in-man applications for this type of therapy due to the immune privileged nature of the eye, thus allowing transplanted cells to be incorporated into the structure, to thrive and to be functional. For those who might be new listeners, RPE cells are nursing cells, which maintain the health of the photoreceptors, the cones and rods that we see with. Among their many functions, the RPE recycle photopigments, metabolize and store Vitamin A, phagocytose shed photoreceptor segments, and transport small molecules between the retina and choroid as part of the visual cycle. Degeneration of the RPE leads to photoreceptor loss in sight-threatening diseases such as AMD and Stargardt's disease. Our approach is to replace the lost RPE in these patients with new healthy cells derived from pluripotent stem cells. The procedure involves a simple injection of dissociated cells into the subretinal space. The cells simply attach to Bruch's membrane and there is no need for them to connect or wire up with the cells in the retina or optic nerve. In preclinical models, this approach resulted in extensive photoreceptor rescue and improvement in visual performance. I'd like to now discuss the results published in the Lancet.

Both the AMD and SMD trials are prospective open-labeled studies designed to determine the safety and tolerability of human embryonic stem cell-derived RPE cells following subretinal transplantation into patients at 12 months, this study's primary endpoint. The studies included 9 patients with dry AMD and 9 patients with SMD for whom a minimal of six months of safety data was available. The report describes the findings on three or four-dose cohorts tested, including three patients each who were treated for both conditions in an ascending dosage format of 50K cells, 100K cells, and 150K cells. Both the SMD and dry AMD patients received a subretinal transplantation of fully differentiated RPE cells derived from the human embryonic stem cells. The median patient age was 77 in the AMD group and 50 in the SMD group. As of the publication, patients were followed for a median of 22 months, as Paul had indicated earlier. After the transplantation of the RPE cells, patients were followed by a series of ophthalmic examinations including best corrected visual acuity, or BCVA, visual acuity testing, slit lamp biomicroscopy, ophthalmoscopy, optical coherence tomography, fluorescence angiography, autofluorescence imaging, and electroretinography. Systemic monitoring included cancer screening, hematologic and serological testing.

Moving to results, to date there have been no serious adverse safety signals detected in these two clinical trials from the transplanted cells. In addition, anatomic evidence confirms successful engraftment of the RPE cells, which included increase in pigmentation at the level of the RPE level after transplantation. Vision improved in most patients after RPE transplantation based on the widely accepted standard for visual acuity testing, the Early Treatment of Diabetic Retinopathy Study, or the ETDRS visual acuity exam. Best corrected visual acuity improved or remained the same in 17 eyes out of 18, and decreased by greater than 10 letters in one eye. 8 out of 18 patients noted an improvement in visual acuity of greater than or equal to 15 during the first year after surgery, which corresponds to a doubling of the visual angle and is generally accepted as a clinically significant measure of improvement. Untreated eyes did not show similar improvements in visual acuity, which suggests a therapeutic benefit of the transplanted cells. Additional results are available in the publication today, but for today I'll stop here. Once again, these results are quite promising and provide guidance for the path forward. We look forward to providing more details from these studies at major medical meetings and updating everyone regularly on the progress as we continue to obtain additional data.

Ted Milles:
To that end, we have asked our shareholders to authorize an increase in the number of shares that we may ultimately issue. On November 12th we will hold our annual stockholders meeting, and the approval of that increase in our authorized shares is critical to the eventual pursuit of capital, and will give us the opportunity to properly capitalize this company and its product development efforts for the next several years. Further to this plan, we recently filed two registration statements with the Securities and Exchange Commission. The first was to register $100 million dollars worth of securities in the form of a universal shelf. This is a very common mechanism that companies use to provide maximum flexibility for potential financing, and it's a good business practice to have one in place. We view this as a strategic move to help support a future financing effort to the benefit of all of our stakeholders, and will remain available to us for several years.

The second registration statement was filed to register the balance of the shares under our Lincoln Park facility. As I said in the past, our relationship with Lincoln Park Capital has been a very beneficial one in that it provides us with clean financing without warrants or any other features that could be viewed as unfavorable to common shareholders. The continued availability of the Lincoln Park arrangement gives us additional flexibility as we evaluate the capital markets.

Va a ser otro dia duro en la oficina me temo ... :(

AMRN

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