Farmas USA

Genio y figura, eres incorregible, jajaja.

34. If Amarin were permitted to make effectiveness claims supported only by credible evidence, such as the heart disease claim on dietary supplement labels, in conjunction with its continuing distribution ofVascepa, the incentives to conduct the REDUCE-IT trial would be significantly reduced. Although I understand that Amarin has stated that it intends to complete the REDUCE-IT trial, it is conceivable that Amarin might choose to forego the trial should it prevail in this lawsuit. Were that to happen, the medical and scientific community would be deprived of the robust scientific data promised by the REDUCE-IT trial regarding the safety and efficacy of Vascepa for the use related to cardiovascular disease.

y esta es una de otras tantas perlas que vienen en el doc de la FDA enviado al juez.
con argumentos tan solidos como estos y con esta municion usada ... los abogados de Amarin se deben estar relamiendo.
Pero como pueden argumentar eso!

AMRN

THLD

Estoy dentro desde ayer con unas pocas....Onty bye bye

OCAT

Sigo con una orden desde ya no sé cuando en 5,10$ por si hay algún bear raid o algo por el estilo, pero nada, esos 5,30 como una roca... Ni para arriba, ni para abajo! Si no estuviera el verano encima creo que ya estaría dentro a esos 5,30.

Seguiré esperando.

NVAX
Quizá no sea lo de ayer, pero hoy apunta maneras también:))

THLD

Estoy dentro desde ayer con unas pocas...Onty bye bye

Sorry, me ha colgado el mensaje dos veces por error

OCAT
Ana, estoy por volver a acompañarte en esta aventura, el año pasado saqué unos buenos profits con esta pájara y veo que está en mínimos de 52 semanas ( el año pasado creo recordar que llego a los 4,8, con tanto el RS donde compro siete soles) acaba de hacer una dilación, con una rápida colocación.
Y los resultados que están teniendo son muy buenos.
Se qué es la niña de tus ojos, pero siendo objetiva como la ves para poder irse al menos de nuevo a los 7 pavos?

OCAT

Stem Cells in Glaucoma Therapy

http://glaucomatoday.com/pdfs/gt0515_F_ou.pdf

The next several years should bring advances.

Primary open-angle glaucoma is the most common form of the disease in the United States, and a subset of patients have normal-tension glaucoma. Current glaucoma treatment aims to lower IOP through medical therapy or surgery. Although decreasing IOP slows disease progression, retinal ganglion cell (RGC) loss and glaucomatous degeneration may continue.1 Novel therapies are clearly needed to replace lost outflow tract cells and to protect and perhaps even replace RGCs. Human stem cells have shown promise and deserve attention, not just in the laboratory, but in the clinical setting as well. This article provides an overview of stem cells for the treatment of glaucoma via neuroprotection, neuroenhancement, and possibly cell replacement strategies.

ONGOING CLINICAL TRIALS

US clinical trials have begun to investigate how neuroprotective therapies may help slow or even prevent RGC degeneration. For example, researchers assessed encapsulated cell implants secreting ciliary neurotrophic factor for safety, preserving vision (neuroprotection), and improving vision (neuroenhancement) in patients with severe glaucoma.2 Although stem cells were not used in this trial and the results have not yet been published, this research is indicative of the field’s movement towards new cell-based neuroprotective therapeutics that avoid multiple intravitreal injections.3,4 Preclinical data have suggested that mesenchymal stem cells such as those derived from bone marrow are neuroprotective when transplanted in rats.5,6

APPROACHES TO STEM CELL-DERIVED THERAPIES IN GLAUCOMA

Most clinical trials using stem cells have focused on neuroretinal degenerative diseases other than glaucoma, and it is not surprising why. Once the optic nerve begins to degenerate in glaucoma, many barriers must be overcome in order to functionally replace these
RGCs. Once implanted, a stem cell-derived RGC would need to migrate to the ganglion cell layer, partner with the appropriate neuroretinal cells, extend axons to the optic nerve head and along the nerve itself, and finally synapse with the correct visual targets in the brain. Although the goal of successfully replacing dead RGCs is unlikely to be reached in the immediate future, preclinical studies of stem cells for cell replacement therapy in the treatment of glaucoma, including optic nerve regeneration, are underway.7 Trabecular meshwork (TM) cell replacement may hold more immediate promise for translation to clinical use. Recently, investigators used human anterior segments in an ex vivo perfused outflow pathway organ culture model to see if stem cells could restore homeostatic function after saponin-induced TM cell loss.8 Human induced pluripotent stem cells (iPSCs) were differentiated into TM-like cells and transplanted into the organ culture model, thereby restoring aqueous outflow. It is exciting to imagine that TM cell replacement by patientderived TM-like cells may one day help physicians to treat patients whose IOP is elevated due to a loss of functional cells in the aqueous outflow tract.

STEM CELL THERAPIES IN OTHER RETINAL DEGENERATIVE DISEASES

Stem cell-derived tissue replacement therapy for other retinal degenerative diseases is already in human clinical trials. In September 2014, a Japanese trial at RIKEN made history with the first human iPSC-derived tissue transplantation ever, which took place in the eye. An autologous iPSC-derived sheet of retinal pigment epithelial cells was surgically implanted in a patient with age-related macular degeneration.9 An update on two cell replacement trials for patients with Stargardt disease and age-related macular degeneration was published recently.10-12 After subretinal implantation of human embryonic stem cell-derived retinal pigment epithelial cells, patients were observed for an average of 22 months. BCVA improved in 10 eyes and improved or remained unchanged in seven eyes. Only one eye experienced vision loss. Importantly, there were no adverse outcomes due to the transplant.

FUTURE DIRECTIONS

Over the next few years, stem cell-derived glaucoma therapies will likely progress in the areas of RGC neuroprotection and neuroenhancement as well as TM cell replacement, all aimed at halting vision loss and perhaps recovering vision. As for pushing the boundaries of stem cell science with RGC replacement and sight restoration, it seems unlikely that the field will advance to human subjects in the near future. That said, only 8 years passed between Yamanaka’s groundbreaking generation of iPSCs and the first transplantation of autologous iPSC-derived retinal tissue into the human eye.9,13 All in all, however, given the complexities of RGC replacement and optic nerve regeneration, the restoration of vision lost to glaucoma will likely require an interdisciplinary approach involving advances in stem cell biology, neuroscience, and tissue engineering.

10. Ocata Therapeutics. Sub-retinal transplantation of hESC derived RPE (MA09-hRPE) cells in patients with Stargardt’s macular dystrophy: NCT01345006. Clinicaltrial.gov. https://clinicaltrials.gov/ct2/show/NCT01345006?t erm=NCT01345006&rank=1. Updated November 3, 2014. Accessed March 25, 2015.

11. Ocata Therapeutics. Safety and tolerability of sub-retinal transplantation of hESC derived RPE (MA09-hRPE) cells in patients with advanced dry age related macular degeneration (dry AMD): NCT01344993. Clinicaltrial.gov. https://clinicaltrials.gov/ct2/show/...1344993&rank=1. Updated November 3, 2014. Accessed March 25, 2015.

12. Schwartz SD, Regillo CD, Lam Bl et al. Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt’s macular dystrophy: follow-up of two open-label phase 1/2 studies. Lancet. 2015;385:509-516