I clearly know knowledge of such systems. Can you provide some more information about systems that could potentially be used to make DCVax-L vs. waiting for EDEN to be ready.
I hate to admit it, but what I'm reading is making me believe that with tweaks to improve the EDEN the vaccine it will be making should be better than what's produced manually. While that sounds great, I don't know that regulators won't say, it's not the same, it must be put through new trials.
Hopefully I'm completely wrong about this, if the regulators are fully aware of this, and have blessed it, we should be fine. On the other hand, if the company suddenly claims DCVax-L1, or any other name, for the vaccine though better, I don't know that new trials wouldn't be required, especially by the FDA.
Hopefully the regulators are flexible to such improvements, many companies wouldn't make them until they timed the improvement to be approved as patents were expiring on the product, thus extending its use with the improved version. Personally, I'd like to see patent law changed to encourage such improvement routinely and additive patent coverage, but it's not what we have today. BP's have improvements for their products that aren't rapidly advanced unless a competitors product looks better, or their patents are expiring. It's not a positive way of getting better products out faster.
Gary
Bullish
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