Farmas USA

perfecto, gracias!

PTLA
me corrijo. parece ser que los resultados del APEX salieron antes de una espectacular caída (dada porque el estudio no alcanzó statistical relevance en un subgrupo de pacientes).
con lo que tenemos resultados, caída, y en las semanas siguientes recuperación casi total, sólo para luego, desde junio, virar al hades nuevamente.
pero la verdad que no acabo de ver lo del estudio, realmente fue tan malo? según entiendo, en el conjunto de la población del estudio fue bien, y si la co no pensara que fue así, no tendría planeado submitir la NDA antes de la conclusión de ningún otro trial

Portola Pharmaceuticals Announces Topline Results from Phase 3 APEX Trial of Betrixaban for Prevention of Blood Clots in Acute Medically Ill Patients
http://topline.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=2150685

EURO/DOLAR

... no me habia fijado en la fea figura que parece esta formando, no??? proyeccion de ser cierta ... cercana a los 1,05 ... ( asi que lo de fea es un decir ;) )

http://inbestia.com/analisis/como-descubrir-que-empresas-van-a-recibir-una-opa

A ver si nos queda claro, jajaja.

NVAX

ja,ja .. me parto con ese post.  que forma de perder el tiempo al que lo lea ...

BCLI

Llegamos tarde al corto. No he visto la noticia hasta ahora.

Brainstorm's NurOwn cells better than placebo in ALS patients, but more complete data needed; shares up 5% premarket

The study achieved its primary objective, demonstrating that NurOwn was safe and well tolerated. NurOwn also achieved multiple secondary efficacy endpoints, showing clear evidence of a clinically meaningful benefit. Notably, response rates were higher for NurOwn-treated subjects compared to placebo at all time points in the study out to 24 weeks.

http://ir.brainstorm-cell.com/phoenix.zhtml?c=142287&p=RssLanding&cat=news&id=2186054

Maxim Group analyst Jason Kolbert reiterated a Buy rating and $5 price target on Brainstorm Cell Therapeutics (NASDAQ: BCLI) after the company announced phase II trial results from the NurOwn trial in ALS. The firm's analysis of the presented NurOwn data suggests a significant signal across multiple secondary efficacy endpoints and a clinically meaningful benefit.

Kolbert highlighted:

Brainstorm announced phase II trial results from the NurOwn trial in ALS. Our analysis of the presented NurOwn data suggests a significant signal across multiple secondary efficacy endpoints and a clinically meaningful benefit. Response rates were higher for NurOwn-treated subjects compared to placebo at all time points in the study out to 24 weeks. We deem the study a success as we believe it creates a solid basis for a pivotal study and defines an approval pathway.
When response to treatment was evaluated based on the absolute point improvement in ALSFRS-R post treatment slope compared to pre-treatment slope over time, again there was strong evidence of a NurOwn treatment effect. See the chart in the attachment, which shows the results for patients who achieved a 1.5 or greater point improvement per month in the ALSFRS-R slope out to 24 weeks. The data shows a benefit in favor of NurOwn at each time point and was statistically significant at 4, 12 and 16 weeks.
Conclusion: We see "good data" that clearly shows an effect, a statistically significant one, which is a lot to expect in a variable disease like ALS and in a n=48 patient PII trial. The results suggest the more active the disease, the greater the effect. We also believe that multiple dosing could show an even greater effect. The phase II trial successfully creates the basis for a pivotal trial. We further believe based on the totality of the data that repeat dosing may show an even more pronounced effect. Lastly, we mention NurOwn continues to demonstrate its safety. As such, the approval hurdle, combined with the unmet medical need, suggests this could be an important new therapy in ALS.

http://www.streetinsider.com/Analyst+Comments/Brainstorm+Cell+%28BCLI%29+ALS+Trial+Results+Robust+-+Maxim+Group/11837634.html

framus-off topic
Si te has fijado habla de la empresa Kofax que fue opada por Lexmark, pues se dio la casualidad de que siguiendo su operativa, la compré cuando lo hizo él y al ser opada sacamos una pasta:))

ADXS

announced that its lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), has been classified as an advanced-therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies (CAT).

http://www.streetinsider.com/Corporate+News/Advaxis+%28ADXS%29+AXAL+Receives+EMA+ATMP+Classification+as+Cervical+Cancer+Treatment/11837035.html?si_client=intbro