Análisis de Pharmamar (PHM), antigua Zeltia

https://youtu.be/M7hjpNqANis

27-11-2020 La noche de los investigadores: "Virólogos por el mundo". Dr. SASTRE HABLA SOBRE PHARMAMAR Y LA APLIDINA

A la pregunta de un servidor: 

Dr. SASTRE: SI ME CONTAGIARA, ME INYECTARIA APLIDIN.
SU ESPOSA: NO TENEMOS ACCIONES; APLIDIN CURA, LAS VACUNAS PREVIENEN.

Espero con ansía viva los comentarios de Siamés. 

 Rumor: " Fuentes internas de Jazz Pharmaceuticals, afirman que la FDA,se posicionará antes de que finalice  este año,sobre si concede el full approval al Zepzelca.El proceso de revisión de la FDA normalmente tarda 6 meses,dependiendo del estado de prioridad del candidato.".El 15 de Junio recibió la aprobación bajo la regulación de accelerated approval,en base a la tasa de respuesta y duración de la respuesta.".No tomen decisiones de compra ni de venta, en base a un rumor.Quedan +/- 20 sesiones de bolsa en este 2020.Así que tomen sus decisiones, de la forma más correcta que sepan... 

https://www.youtube.com/watch?v=smQMQG8bBfQ&t=5s

Le sigo por You Tube y le agradezco que se preocupe.

Yasmin de los Andurriales:  El full approval al Zepzelca es independiente del estudio Atlantis, verdad?

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213702Orig1s000ltr.pdf

Products approved under the accelerated approval regulations, 21 CFR 314.510, require further adequate and well-controlled clinical trials to verify and describe clinical benefit. You are required to conduct such clinical trials with due diligence. If postmarketing clinical trials fail to verify clinical benefit or are not conducted with due diligence, we may, following a hearing in accordance with 21 CFR 314.530, withdraw this approval. We remind you of your postmarketing requirement specified in your submission dated May 21, 2020. This requirement, along with required completion dates, is listed below.

3831-1 Submit the final report and datasets for the overall survival and progression-free survival analysis as determined by an Independent Review Committee from a clinical trial to confirm the clinical benefit of lurbinectedin in small cell lung cancer that may inform product labeling.

This could be from the Study titled, “Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinumcontaining Line (ATLANTIS)”.

Final Protocol Submission: 05/2016 (completed)
Trial Completion: 02/2020 (completed)
Final Report Submission (OS): 02/2021