#62241
Re: Farmas USA
Pues la FDA les habia dado todos los honores ...
"The treatment was granted both "breakthrough" and "fast-track" status by the U.S. Food and Drug Administration."
Una lastima ...CLDN
Se está hablando de:
#62242
Re: Farmas USA
CLDN
Pierde 4/5 de su valor... ¡vaya palo!
#62243
Re: Farmas USA
CLDN
Avisé. Y sí, otras como BLUE, AAVL se contagian.
El viernes me preguntabas por STEM. Sí, es competencia de ACTC, pero no le llega ni a la suela de los talones. Y hace no mucho uno de sus directores denunció que no se han seguido las buenas prácticas, que se han contaminado las líneas de células y que se ha puesto en peligro a los pacientes. Y la empresa lo puso de patitas en la calle. Vamos, que con semejante plantel no llegará a nada bueno.
#62244
Re: Farmas USA
CLDN.
Pues algo huele a podrido en Dinamarca.
"Shares of Celladon Corp (NASDAQ:CLDN) were the recipient of a large growth in short interest in the month of April. As of April 15th, there was short interest totalling 4,826,704 shares, a growth of 65.6% from the March 31st total of 2,914,567 shares, AnalystRatingsNetwork reports. Based on an average daily trading volume, of 1,562,953 shares, the days-to-cover ratio is presently 3.1 days. Approximately 42.4% of the company’s shares are sold short"
http://www.wkrb13.com/markets/567867/short-interest-in-celladon-corp-rises-by-65-6-cldn/
No puede ser casual....
#62245
Re: Farmas USA
#62246
Re: Farmas USA
CLDN
No es casual. El 31 de marzo precisamente empezó a salir la información. Yo la puse aquí.
Según 10K EMA may find CUPID 2 data inadequate for approval
Bastardo: Might close the door on possibility of EU filing based solely on positive CUPID-2. $CLDN still needs CUPID-3 for U.S. filing.
AndyBiotech: EMA not satisfied that adequate control of type 1 error by the joint frailty model to be used for primary efficacy analysis of CUPID-2
Subgrupos no funcionan:
http://www.ozgurogut.com/thoughts/2015/3/31/itt-treasure-hunt
CEO confirms on call that another trial will be needed for EMA approval if CUPID-2 barely hit the primary endpoint.
#62247
Re: Farmas USA
NAVB
Desinversión en su fármaco para el párkinson y terminación de la licencia con Alseres
Under the terms of this agreement, Navidea will transfer the NAV5001 IND, all data, clinical materials, regulatory files (including the Special Protocol Assessment agreements), patents, know-how, and other assets covering the clinical testing of the NAV5001 to Alseres. Alseres will reimburse Navidea on a fully-documented, pass-through basis for any incurred maintenance costs of the contract manufacturer retroactive to March 1, 2015. In addition, as requested by Alseres, Navidea will supply clinical support services for NAV5001 on a cost-plus reimbursement basis. In consideration for the rights granted to Alseres, Navidea will receive a milestone payment in connection with NAV5001’s NDA approval by the U.S. FDA and a royalty on subsequent net sales of NAV5001.
#62248
Re: Farmas USA
Juas, les ha durado Anne Whitaker tan solo 9 meses como CEO!!!
Pues era una tipeja muy partidaria de buscarse partnership con una grande ...
SNTA
