Farmas USA

Pueden salir más resultados juntos?!?!?

Y yo con un pu** móvil

ACAD

Dios, esto es un pozo sin fondo... a ver cuando aprendo a cortar por lo sano a tiempo.

joooooo, totalmente en contra de lo por mi esperado,  

ACHILLION REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

PDF Version

- Global phase 2 clinical programs for ACH-4471 continue to expand in PNH and C3G -
- Completed dosing phase 1 clinical study of ACH-5228 and initiated phase 1 study of ACH-5548 -
- June 30, 2018 cash position $295.8 million -

http://ir.achillion.com/news-releases/news-release-details/achillion-reports-second-quarter-2018-financial-results

Nvax

De lo que se viene (no se si ya era conocido)
Final efficacy results of the Prepare trial are expected in the first quarter of 2019.

The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018.

Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019.

Novavax Reports Second Quarter 2018 Financial Results

Novavax Delivers on Key Milestones Supporting its 2018 Objectives

Company to Host Conference Call Today at 4:30 pm ET

GAITHERSBURG, Md., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the second quarter and six months ended June 30, 2018.

“In keeping with our stated 2018 objectives, Novavax reached two important milestones in the second quarter for our lead ResVax™ and NanoFlu™ programs,” said Stanley C. Erck, Novavax President and CEO. “With ResVax, we achieved a critical enrollment goal in the Prepare™ trial, enabling us to reach agreement with the FDA to initiate a final efficacy analysis in the first quarter of 2019. This analysis will be used to support the future BLA and MAA in the U.S. and Europe, respectively.”

http://ir.novavax.com/news-releases/news-release-details/novavax-reports-second-quarter-2018-financial-results

Si, la hoja de ruta sigue intacta.

Si acaso estas dos matizaciones:

Novavax recently reached agreement with the FDA that the efficacy analysis to be conducted in the first quarter of 2019 will be the final analysis used to support the future biologics license application (BLA). This agreement was based on meeting the FDA’s minimum standards for evaluation of both the safety and efficacy of ResVax. We anticipate using the same data for filing a marketing authorization application (MAA) submission in Europe. The current and projected numbers of blinded primary endpoint cases provide Novavax with confidence that the trial is powered to make a statistically sound efficacy conclusion. Novavax expects to report on these data in the first quarter of 2019 and, assuming successful results, expects to submit the BLA and the MAA by the first quarter of 2020

In June 2018, the FDA acknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu

nvax