NVIV
Además del hold, ayer sacó un filling para añadir las cláusulas de que igual no sobrevive y resulta que también tiene una advertencia por inspección de la FDA
In July 2017, enrollment of patients in The INSPIRE Study of our Neuro-Spinal Scaffold implant was placed on hold following the third patient death in the trial... we have been in discussions with the Food and Drug Administration (the “FDA”) to define a clinical path forward. As part of the ongoing discussions with the FDA we have proposed a randomized controlled trial to supplement the existing clinical evidence for the Neuro-Spinal Scaffold implant. We do not anticipate reopening enrollment in The INSPIRE Study and
we expect to provide additional clarity on our clinical path forward in the second quarter of 2018. We are required to obtain FDA approval before we will be permitted to resume any clinical trials with respect to Neuro-Spinal Scaffold implant. We cannot be certain that we will be able to define a clinical path forward, or that we will be able to raise the funds necessary for the clinical path that is required by the FDA.
Our current
cash resources will not be sufficient to complete clinical development of our Neuro-Spinal Scaffold implant. If we are unable to define a clinical path forward in a timely manner or in a manner that aligns with our cash resources, or it we are unable to raise capital, we may be forced to cease our operation entirely.
in December 2017, we and several of our clinical sites and our CRO were subject to an FDA inspection in association with The INSPIRE Study. At the close of the inspection at InVivo, the
FDA issued a Form 483 with two observations relating to our over oversight of clinical trial sites in The INSPIRE Study
Y el día 26 llegó a un acuerdo con Lincoln de financiación. Los mismos que llevaban ACTC/OCAT. Vamos, diluciones sin cuidado ninguno.
$15 million in shares of common stock to Lincoln Park over a twenty-four-month period,
https://finance.yahoo.com/news/invivo-therapeutics-announces-purchase-agreement-130000980.html
«Después de nada, o después de todo/ supe que todo no era más que nada.»