You're spot on James, but best to stay out of the way of the cheersquad when they are on a tear.
I'd normally be a bit skeptical about claims of a working therapy when only one of 25 evaluable participants had a CR, however, prepared to accept that it was due to CF33 in this case for two reasons:
1. The scan showing the initial enlargement of the tumour followed by its shrinkage was how Professor Fong explained it would work.
2. Evidence that CF33 was present in the tumour cells.
So that's all good.
I also liked that Paul Woodard was reserved about the results. Whenever he was pressed about the opportunity to fast-track FDA approval, he basically avoided the question. I suspect that he's well aware that you can't jump to any approval process when all you've done is prove safety.
With respect to efficacy most of the speculation is just that since 1/25 is not going to cut the mustard:
- it may work better with higher doses;
- it may work better as an earlier line of treatment;
- it may provide a positive indication re: Oncarlytics
but none of these things have been proven just yet.
I put Leslie's "stay tune(d)" comment in the "dance cards full" category. As you noted, it may be interpreted as "we're already on the path to seek short-cut approval from the FDA, I'm just not allowed to say anything yet" or it may just be "as we progress, if higher-doses and earlier-stage treatments prove successful, we may be able to make an approach to the FDA".
I suspect the latter. What's the point in being oblique to questions about fast-track approval? The products are covered by patents, so there is no competitive risk in this regard. I'd prefer to hear more of Paul W's realistic appraisals and less of Leslie's oblique exuberance. It would also be a good sign if they were interviewed by someone that the didn't have to pay ...
I'm also suspicious about the timing of the announcement. It wasn't made at any particular milestone. Could have been made weeks ago, could have been made in some weeks. But when you look at the timing of the upcoming AGM and likely 2nd strike, it makes more sense. And hasn't it worked a treat. If you had said to the cheersquad, 10c at the start of the year, you would have been abused. Now they love 10c since they've seen 4c.
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