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Farmas USA

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#105353

Re: Farmas USA

Pero cuáles son los secondary endpoints? Han tomado el OS como secondary?
FGEN

#105357

Re: Farmas USA

FGEN

¿Y no hay un enlace a algo? Esa información que hay ahí tiene toda la pinta parcial o tendenciosa.

Le acabo de echar un vistazo a los ensayos de FGEN y solo hay uno (que tengan fichado en EE. UU., claro) que cuadre.

Y que hablen de extirpación y no de OS es muy lógico, porque las últimas investigaciones en cáncer de páncreas van encaminada a hacer que los tumores encojan para poder extirparlos. Básicamente la diferencia entre vivir y morir radica entre poder extirpar o no. Por lo general la gente palma porque para cuando lo localizan ya se ha extendido.

 

Primary Outcome Measures :

  1. Safety [ Time Frame: Through 28 days following the last dose of study treatment ]
    Asses the treatment-emergent adverse events (TEAEs), serious treatment-emergent adverse events (TESAEs), clinical laboratory tests, and discontinuation of treatment for treatment-related TEAEs.
  2. Surgical safety with respect to complication rates post resection [ Time Frame: 30 days following discharge after surgery ]
  3. The proportion of subjects who become eligible for surgery [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  4. The proportion of subjects in whom R0 resection is achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  5. The proportion of subjects in R0 or R1 resection is achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
  6. Tumor response rates [ Time Frame: After completion of 24 weeks of treatment with study drug ]
    Measured by: complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least 50% reduction from baseline in serum CA19-9, or at least 30% reduction from baseline in SUV[max] assessed by FDG-PET
  7. Median overall survival and 1-year survival rate [ Time Frame: At least 28 weeks following completion of 24 weeks of treatment (52 weeks) ]
  8. Median progression free survival and 1-year progression free rate [ Time Frame: At least 28 weeks following completion of 24 weeks of treatment (52 weeks) ]

https://clinicaltrials.gov/ct2/show/NCT02210559?term=FibroGen&draw=2&rank=16

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#105358

Re: Farmas USA

FGEN

Me he mirado los PR de este año. Solo hay dos de páncreas. Son los dos del mismo principio, pero el primero es el que cuadra con la información.

http://phx.corporate-ir.net/phoenix.zhtml?c=253783&p=irol-newsArticle&ID=2282394

“Phase 2 clinical studies of pamrevlumab have produced initial positive data on median and one-year survival for patients with advanced pancreatic cancer (88% metastatic). An ongoing study in locally advanced non-resectable pancreatic cancer has shown promise in converting pancreatic cancer from non-resectable to surgically viable. In this current open-label Phase 2 randomized trial, we are evaluating pamrevlumab in combination with chemotherapy standard-of-care versus chemotherapy alone. We look forward to sharing results by early next year.”

Y el otro:

FibroGen Announces Publication of Pamrevlumab (FG-3019) Clinical Data in Pancreatic Cancer Showing Safety and Improved Survival Outcomes in Combination with Chemotherapy

dose-escalation Phase 1/2 study (FGCL-MC3019-028) of pamrevlumab in pancreatic cancer

The published results support a dose-related increase in survival in advanced pancreatic cancer, and that pamrevlumab can be safely combined with chemotherapy.

In the 028 trial, the safety and efficacy of increasing doses of pamrevlumab were evaluated in combination with two chemotherapy agents, gemcitabine and erlotinib, in 75 patients with previously untreated Stage III or Stage IV pancreatic ductal adenocarcinoma. Pamrevlumab was well tolerated with no dose-limiting toxicity observed and no dose-related trends observed in type or incidence of serious adverse events. Toxicity, tumor response by CA19-9 and CT scan-based RECIST criteria, progression-free survival (PFS) and overall survival (OS) were assessed

http://phx.corporate-ir.net/phoenix.zhtml?c=253783&p=irol-newsArticle&ID=224206

 

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#105359

Re: Farmas USA

Aquí unos screeners donde puedes buscar por sector y capitalización de mercado

https://www.finscreener.com/screener

https://www.marketwatch.com/tools/stockresearch/screener/

https://www.screener.reuters.wallst.com/stock/us/index?quickscreen=gaarp

Se los podemos pedir por favor para añadirlos al ProReal :)

 

Y este es personalizable:

https://finbox.io/screener/temp/edit/filters

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#105360

Re: Farmas USA

 

Melinta Therapeutics registers $150M mixed shelf offering

 

https://seekingalpha.com/news/3325870-melinta-therapeutics-registers-150m-mixed-shelf-offering

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Despues de tanto M@A que podiamos esperar , mucho habian demorado, y eso que hace pocos dias ya soltaron un Offering a 16.60 usd, lo que segun el  CEMP - Sesasional chart 2017 en Marzo toca subir y  bien, Veamos que nos cuentan en el Q4 ER y en el anual ER, y como han empezado las ventas de  Baxdela, (an antibiotic approved by the United States food and drug administration (FDA) y los otros anttibiotcos que ya estan en el mercado  de su reciente aqusicion y de los fondos BARDA para Soli ya aprobados para Soli en pediatria, etc, etc 

ORBACTIV® (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs

VABOMERE™ (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex

MINOCIN® (minocycline) for Injection is indicated for the treatment of infections due to susceptible isolates of designated microorganisms, including Acinetobacter species bacteria.

http://melinta.com/products/

 

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