CYTX
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http://biz.yahoo.com/e/141107/cytx10-q.html
Paran por lo pronto el estudio cuya reanudación ha autorizado la FDA (ATHENA) para analizar los datos. También paran por ahora otro estudio de células adiposas regenerativas que estaban iniciando y otro ortopédico (RECOVER). Mmmm. No me huele muy bien
during the delay the Company has made substantial progress on it next generation Celution® system, the Company has determined the most prudent course of action is to stop enrollment at 31 patients and analyze unblinded six month data. The 31st patient will reach the planned 6 month time-point this month. An analysis of the complete and verified 6 month data should be available early in 2015 for review and planning next steps.
adipose-derived regenerative cells (ADRCs) in the therapy of patients with end-stage heart failure already on a left ventricular assist device or LVAD in a trial called CELVAD. Recently, the NHLBI informed Cytori that initiation of a cell therapy trial on patients with LVADs will be delayed citing concerns around the feasibility related to treatment of LVAD patients, evolving nature of LVADs, endpoint selection, and the cost and complexity of the study. We will provide updates on the outlook for this trial when we are notified.
Inician uno ortopédico
eceived approval by the FDA to begin a US IDE pilot (phase II a/b) clinical trial of Cytori Cell Therapy in patients with osteoarthritis affecting the knees to be called ACT-OA. A total of 90 patients will be enrolled in this randomized, double-blind, placebo controlled clinical trial and followed for one year. The study, which is anticipated to begin enrollment in 2015, will examine the safety of Cytori Cell Therapy and several efficacy endpoints including symptom relief, function and activity level. Data should be available in 2016.
Participan en otro de escleroderma
Cytori has agreed to support a follow up confirmatory trial in France.
BARDA executed a significant contract extension option for ongoing research and development activities required to enable a pilot clinical trial of Cytori Cell Therapy in thermal burn treatment;
Resumen: Cytori intends to: finalize ATHENA and analyze the data, start the ACT-OA trial, wind down the RECOVER trial, support the initiation of its scleroderma and urinary incontinence trials in Europe and Japan respectively, file for CFDA class I approval, complete the next phase of the Celution® development program, and work with BARDA and FDA to plan our forthcoming thermal burn trial, among other activities. Financially, we intend to continue to improve our financial position through combination of activities including: additional expense reductions, profitable revenue growth, additional capital raise, partnerships, debt restructure or further debt term modification.
http://finance.yahoo.com/news/cytori-reports-third-quarter-2014-210500145.html
«Después de nada, o después de todo/ supe que todo no era más que nada.»