learningcurve2020,
Manufacturing approval as well as manufacturing ramp up plans are part of any marketing application package. Investor benefit comes from having a manufacturing plan that works for MHRA, FDA or any regulator that can ask for specific clarification in that regard or question anything that they are uncertain about the company being able to achieve vs what they say they will do in the application. The fact that MHRA knows that manufacturing is changing and is obviously part of the plan for ramp up means they would likely want assurances that process development is on track and will not cause disruptions to treatment access because it’s not. Seems pretty obvious to me anyway; ).
By the way, a subset approval would be foolish if the product would be used off label anyway with Poly ICLC and in combos for GBM, rGBM and lower grade gliomas because of long term evidence already in the public domain. I don’t think MHRA wants to look like they don’t know what they are doing in this regard by being backward thinking and allowing other jurisdictions the opportunity to get the jump on them with an expanded label. Best wishes.
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