Chuigray, we certainly have a CEO that knows the law, I've got to believe that before making that statement she's discussed it with the regulators. If not, a Phase 1/2 could probably be done quickly into the Phase 2 portion and that could be expanded into a full Phase 2 if data warranted doing it. If it didn't, no sense in going into a Phase 3 trial.
If the means of producing even Phase 1 material is worthy of being used in a pivotal trial the regulators are generally willing to have trials morph into higher levels so all patients can be considered a part of the data if they were on the pivotal trial protocol. Essentially, such a trial is never halted, it evolves to add more patients so time isn't wasted going from one phase to the next one.
The DSMB can at any time recommend early approval if the data's overwhelmingly good, or ending the trial if it clearly isn't worthy of an approval. To my way of thinking, if a DSMB says a product should be approved, at that point the regulators should issue an EUA permitting the product to be sold until an application for approval can be generated and reviewed, which often takes at least a few years.
The Covid 19 vaccines no doubt saved many lives because an EUA was issued well in advance of the full approval, yet Covid only killed a small percentage of all who got it. A severe cancer, like pancreatic, probably kills 99% of those who get it and aren't eligible for the Whipple procedure in under 5 years. If an EUA brought 99% down to under 90%, that's a marked improvement, why wait for years to approve it. DCVax-Direct could be a tremendous advancement for the majority of pancreatic cancer whose tumors are inoperable. Even those eligible for the Whipple ought to be pretreated with Direct to prevent the Mets from returning and ultimately killing the patient.
All this discussion would be completely unnecessary if the FDA and drug developers could agree to a right to try price that made the product available once it was seen to have benefit, regardless of what stage the trials were in. As currently established, right to try is essentially right to nothing because drug developers are unwilling to give the regulators the information they demand to put them in the program. I have no idea what information NWBO, or perhaps Advent, had to provide to the UK regulators to establish the price they'd get for using the vaccine under compassionate use.
Gary
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