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Farmas USA

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Farmas USA
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#105450

Re: Farmas USA

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.»

#105451

Re: Farmas USA

LABD

Soltadas a 3,18 Han dado su fruto. Pensaba esperar a los 114 del ibb pero prefiero ir entrando y saliendo que quedarme dentro de estos bichos x3

#105452

Re: Farmas USA

ZIOP

Leñe! No me acordaba tenía orden en 4,24... Así que estoy dentro

#105453

Re: Farmas USA

ACAD

Fuera 31,58

KERX

Fuera

4,78

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

#105454

Re: Farmas USA

La leche que llevan los índices. Ya veremos hasta donde llega la sangría.

#105455

Re: Farmas USA

Me he atrevido a otro mete/saca en Nvax, dos paquetes rascandole 4 y 5 centavos en cada uno. Espero no llevarme un susto cualquier dia.

NVAX

#105456

Re: Farmas USA

Con dos.. torero

NVAX

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