Well, we don't even know if they have applied, so I am skeptical of MHRA approval "any day." In their July guidance, MHRA said anyone looking to participate in the streamlined process could begin using the new system THEN. And, starting in January, the new process would be in full effect. What they don't say is how ling the process takes. All they claim is a 30% reduction in time to get an approval, if warranted. How could we apply for this without TLD? How could they submit unblinded data for this without releasing to public? Just don't see it.
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