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PVCT Provectus Biopharmaceuticals
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The second poster Has had me thinking ever since I read the abstract. Mgmt isn't satisfied with the results of the uveal trial. Not that they weren't the best we've seen so far, but the second poster is showing a dramatic increase in Stable Disease and even a CR in an injected tumor. I'd be trying to highlight that if I were mgmt also. But what does this mean moving forward? If the goal is to show the FDA what you've got, then why show them data based on a RECIST that's not accurately reflecting the results of the trial? Sure, the FDA could grant something on just the 36% ORR alone, but if we're more accurately sitting at a 50,60 or 70% ORR then an attempt needs to be made to present this outstanding data to the FDA, BP or even future investors/groups. If a patient is injected with PV-10 and then after a certain time is x-rayed and the tumor is the same size or even larger, the trial marks that patient down as having been Progressive Disease. That hurts our trial results. Then, after the patient has already been marked as PD, they come back in for a follow-up x-ray and it shows Stable Disease, Partial Response or even Complete response, the patient isn't re-entered into the trial and the PD isn't corrected to show the actual results. It's not just our trial that getting hosed up, there's a human being that has a disease that's being effectively treated that is out of the drug administrative portion of the trial when they would have normally been eligible to receive additional PV-10 injections! Now the RECIST assessment is really messing things up by causing undue stress on a person that desperately needs good news or potentially sealing these patients fate. So where do we go? Can the FDA simply allow a change to another evaluation protocol like the second poster is suggesting/requesting? Can patients previously marked as having PD re-enter/continue where they left off if the FDA accepts a change? Or do we simply have to accept the fact that we're probably showing HALF the efficiency of our drug and we simply have to take it on the chin and continue with unfair trial results? I'll all but guarantee that Dom and Eric saw the followup x-rays and knew they had to act. Maybe they spoke with the FDA already and they couldn't change the evaluations protocols on the fly. Maybe they haven't had a chance to speak with the FDA yet. Maybe they figured that, while they have people's attention from the original poster presentation, they may as well follow up with the second poster to show people that there's a lot more to our trial than the original trial is showing. I hope the FDA is reasonable in dealing with this situation. Our 36% ORR as very impressive as it is. But we're seeing, pretty much, staggering real-world results that need to be acted upon by the FDA sooner rather than later. As far as BP goes, I think this second poster is important because any future trials ran in combo with their respective immuno therapy will probably be written in such a way that calls for the immuno assessment protocols anyways. This gives them a more accurate picture as to what to expect. This second poster is important. Otherwise, we're going to continue to recruit patients into a trial knowing fully well that they have a solid chance at good success despite the probability that they'll likely hurt our trial numbers and potentially be removed prematurely. Anyway, forgive the long ramble. I've just been thinking a lot about this second presentation, what it means to us, the FDA, BP and potential future investors. Thoughts? |
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