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Re: IkeEsq post# 402083

Wednesday, 09/15/2021 8:08:09 AM

Wednesday, September 15, 2021 8:08:09 AM

Post# of 704410
Ike, Are the not approved to run an Early Access Program in the US? I may be mistaken. That does require FDA approval BTW. It is treated similarly to a study but you can charge patients for cost of goods delivered. If my recollection is correct, patients never needed right to try legislation, they just needed action on an EAP.

If you are referring to legally defined harm, I would defer to your opinion. Certainly, pressure to move EAP forward with study sites does not seem to be happening and would not be expected before data release. CRL can provide all the drug cash paying US patients will need and the experience of running logistics and support would benefit all patients in the immediate post launch period. This two tiered system separates the middle class from the wealthy, however, which doesn’t sit too well for too long. I give them a pass on EAP until Oct 2020 plus a few months. After that, it is helpful to exert pressure.
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