Farmas USA

Sigo dentro. Confio en ella. La semana que viene quzas me quito un 30% pero no mas. Me la jugaré. Cons 2 Phase II a la vez, alguna de las dos sera positiva, o las dos. Para mi el riesgo es bastante menor que la recompensa. Y a ver si la devuelven al 6$ antes de resultados.

Y si, hoy ha estado bien..

No encuentro el link , pero copio y pego lo que he encontrado en stocktwits:

$AMRN Goldman note out late afternoon just noticed. Cited 3 issues focus of appeal :
1) no mention of needing a CV outcomes study in any of the communications between AMRN and FDA
2) other cv outcome studies using tg lowering agents not appropriate to compare across to V as they used diff drugs in diff populations and
3)AMRN was seeking an indication for TG lowering (not cv risk) and it was unfair to pose question to FDA panel of whether V could reduce cv risk as ANCHOR was not designed to answer that question.

We remain cautious about the potential to expand the indication down the road. We lower our price target to $2.30 from $2.50.

AMRN

Premarket de AMRN abierto ya. Subida hoy???

Saludos.

Fijaros siempre en el volumen ...

Hola Framus.

Ya... sólo 200 acciones, sí, pero son las 11:50... quedan 3,5 horas hasta la apertura... esto no es normal en AMRN... por eso me choca...

Saludos.

Genzyme

Ha salido el briefing document. Según mi lectura y a pesar de que no controlo la historia esta, el panel será positivo añadiendo un procedimiento de control especial:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM374187.pdf

Pues no conozco apenas el sector, yo entré el viernes con muy poquitas en AMRN y todo consejo es bien recibido. De momento, en preapertura es verdad que hay muy poco movimiento, pero alguna mano caliente ha movido ficha a 1.78 dólares.

Esperaremos a la apertura a ver qué tal.
También ando siguiendo a ZLCS, pero no he entrado aún.

GALE

Presenta buenos datos de seguridad y dice que pasan a fase II

The poster presentation entitled "Phase 1 Trial Results of a Folate Receptor Alpha-directed Cancer Vaccine (E39) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence," showed that the FBP vaccine is both safe and immunogenic. The primary outcome of the Phase 1 trial was to determine safety and the optimal dose, with a secondary outcome to look for an initial efficacy signal and immunological response. The optimal dose was determined to be 500 mcg peptide combined with 250 mcg GM-CSF. FBP proved to be well tolerated, with largely Grade 1 toxicities, primarily consisting of injection site reactions. After a median follow-up of six months, there have been 2 recurrences (13.3%; n=15) in the vaccine group vs. 4 recurrences (25%, n=16) in the control group, although the trial was not powered for any efficacy measurements.

"New approaches are needed for ovarian and endometrial cancer patients who face a high risk of disease recurrence. The initial results from the Phase 1 trial show that the FBP vaccine may be a potential cancer immunotherapy treatment to prevent recurrence in these high risk patient populations," concluded Dr. Erika J. Schneble, San Antonio Military Medical Center, San Antonio, TX who presented the results at the SITC conference.

The Phase 1 component was a 3x3, dose-escalation, safety trial enrolling disease-free endometrial and ovarian cancer, HLA-A2 positive patients into the vaccine group, while HLA-A2 negative patients were being followed prospectively as an untreated control group. Six monthly intradermal inoculations of either 100mcg, 500mcg, or 1000mcg of peptide vaccine + 250 mcg GM-CSF immunoadjuvant were administered during the primary vaccine series. Immunologic responses were assessed by both local reaction after each inoculation and by delayed-type hypersensitivity (DTH) reaction measured pre-vaccination and after the primary vaccine series. Recurrences are determined clinically. Thirty-one patients were enrolled in the Phase 1 trial: 15 in the vaccine group and 16 in the active control group. There were no significant differences in age, grade, stage, or nodal status between groups. Overall, the vaccine was well tolerated with the majority of local and systemic toxicities Grade 1 (maximum local toxicity: 93% Grade 1; maximum systemic toxicity: 60% Grade 1). Local skin reactions increased from the first to the third injections, and then plateaued for the remainder of therapy.

"We are encouraged by the initial results of our Phase 1 trial with the FBP vaccine, showing that it is well-tolerated and demonstrated promising immune responses in high risk gynecological cancers," said Mark J. Ahn, President and Chief Executive Officer of Galena Biopharma. "As a result, we are moving forward with the Phase 2a component which will be initiated by year end and will include the enrollment of additional patients at the optimal dose as well implementing a booster regimen."