Re: Farmas USA
INO
De la conferencia:
let’s put the situation in perspective, we did not announce a safety issue in a study that is already enrolling and treating patients. This is a request for further information prior to the initiation of our phase 3 program. And this delay at the beginning may not necessarily affect our approval timeline at the end. Also, this hold questions about this phase 3 device have no effect, I will say it again, no effect on any of Inovio’s other ongoing clinical studies. Here is where we are, of all the phase 3 preparations we had to complete, the final step was submitting to the FDA our clinical or immunotherapy product and new device package for the phase 3 program. We submitted this comprehensive package in September on time with the goal to initiate the phase 3 in November and we were fully prepared to do so.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
