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Sunday, June 12, 2022 10:37:53 PM
I actually do not believe manufacturing is standing in the way of approval. Car-T companies are still using manual production and are already approved in the UK and can barely meet demand. I do not think it appears that DCVwx will be in the same position, and I think the MHRA likely is well on its way to knowing that to be the case. Even in the US, to get accelerated approval, you do not need all manufacturing to already be in place, you need to have the regulator comfortable that you have a plan to scale up. I think they probably have that with contingencies and more already.
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