Sunday, December 05, 2021 9:44:43 AM
I would add that I therefore believe FDA wishes always comes first unless they are being unreasonable and you just have to do what is best for your business. I have always said that FDA is reasonable, has empathy, and will even bend rules sometimes in order to do what is right. If they think it will be a tough sell job to the American people, they hold an Advisory committee with public feedback where they are quite literally asking patients and clinicians voice be heard. They will generally override the committee to align with patient/clinician voice, if necessary. They are very good at what they do.
I think if necessary GBM patients, physicians, physical therapist, psychological therapists and 2nd or 1st most importantly caregivers would come out in full force to support DCVax approval. I think FDA knows this and would deem that process unnecessary. They may even work to coordinate this with all parties involved, especially the EMEA, but also certain journal editors if that is best for all.
What I don’t understand is how anyone could see this as FDA not being onboard. I can’t believe anyone can’t see that is a slam dunk, AND that is my opinion
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