From the science and approval side, I would say this is correct. And so I would agree that from NWBO's perspective, DCVax-L has been substantially derisked.
However, from an investment perspective, there is another strong risk. And that is the financial status of the company. They need to start bringing in revenue quickly, or they will have to do additional fundraising to stay solvent. Not a problem for the product. Enact a reverse split, uplist, sell shares at a discount, plenty of money available. However, for the current investor base, that is a major problem. This risk cannot be overlooked. What is the timeline? Is there going to be enough good news, soon enough, to support a productive fundraising before these more drastic measures are necessary?
We simply don't know the timeline. If you guaranteed me the journal, TLD, and BLA status were all coming in the ASCO timeframe I would definitely agree we are substantially derisked. But that guarantee certainly can't be made and, as such, there is still substantial risk to consider.
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