Saturday, March 29, 2025 4:18:32 PM
Krisgo, If as rumored, inspections took place in Jan and Feb 2025, then we are continuing to move along. Just thoughts, but what could be happening is an effort by the MHRA to time the approval of DCVax-L to coincide with the approval and validation of Flaskworks' Eden automation system.
I think this because the Eden validation process has likely been running in parallel all along. Also I believe the MHRA considers this, knowing that once a drug approval happens, the company is obligated and will be pressured to invest heavily in the ramp up for commercialization. These would include long-term, hard financial commitments (especially long tail order requirement items), especially in manufacturing. If in fact the approval decision for Eden was right around the corner, or potentially within a couple of months, those would be the judgement calls they would make. And I assume nothing is clear and simple with regards to a couple of months either, given the MHRA has been backlogged.
I think this because the Eden validation process has likely been running in parallel all along. Also I believe the MHRA considers this, knowing that once a drug approval happens, the company is obligated and will be pressured to invest heavily in the ramp up for commercialization. These would include long-term, hard financial commitments (especially long tail order requirement items), especially in manufacturing. If in fact the approval decision for Eden was right around the corner, or potentially within a couple of months, those would be the judgement calls they would make. And I assume nothing is clear and simple with regards to a couple of months either, given the MHRA has been backlogged.
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