Moxa, I believe what you're suggesting may be v
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Posted On: 06/10/2018 7:08:42 PM
Moxa,
I believe what you're suggesting may be very possible, but it's not documented in what we've been able to look at. The trial filing that's in the clinical trials database is purely a Phase 1 in healthy patients. Is it possible that since then the trial as it's being run has become a Phase 1/2 Trial where once safety is proven as Phase 1, with the most effective dosage determined, they move into a Phase 2 portion where the drug can be tried with patients who have psoriasis. This is not what the timeline shows, it shows a separate Phase 2, but it's not impossible that one has morphed into the other. Even if that should be the case, I see no reason the company cannot say the Phase 1 portion of the trial has successfully ended, and give the top line info from that part of the trial. It would be quite positive if they also said we are now trying the drug in patients with the disease, and give us some guidance as to how many patients and how long they anticipate that taking.
Companies use the clinical trials database to attract patients to trials. It may very well be true that OWCP doesn't need this. It is very possible that Sheeba, and other clinical sites in Israel already have plenty of volunteers lined up, and their is no law that says that to do a trial you must be in the clinical trials database, in fact it seems that in Israel the full authority that must be convinced is the IRB and I have no idea how open they are to making modifications during the trial. Going from a Phase 1 to a Phase 1/2 would be such a modification.
I should add, we have no guidance on what the protocol of the fibromyalgia trial is, and it should be underway if the last update we've seen from the company is true as best I remember.
In many ways, OWCP is like that iceberg often seen in photos where so little can be seen, but so much exists below the water where it's invisible to practically everyone.
Gary
I believe what you're suggesting may be very possible, but it's not documented in what we've been able to look at. The trial filing that's in the clinical trials database is purely a Phase 1 in healthy patients. Is it possible that since then the trial as it's being run has become a Phase 1/2 Trial where once safety is proven as Phase 1, with the most effective dosage determined, they move into a Phase 2 portion where the drug can be tried with patients who have psoriasis. This is not what the timeline shows, it shows a separate Phase 2, but it's not impossible that one has morphed into the other. Even if that should be the case, I see no reason the company cannot say the Phase 1 portion of the trial has successfully ended, and give the top line info from that part of the trial. It would be quite positive if they also said we are now trying the drug in patients with the disease, and give us some guidance as to how many patients and how long they anticipate that taking.
Companies use the clinical trials database to attract patients to trials. It may very well be true that OWCP doesn't need this. It is very possible that Sheeba, and other clinical sites in Israel already have plenty of volunteers lined up, and their is no law that says that to do a trial you must be in the clinical trials database, in fact it seems that in Israel the full authority that must be convinced is the IRB and I have no idea how open they are to making modifications during the trial. Going from a Phase 1 to a Phase 1/2 would be such a modification.
I should add, we have no guidance on what the protocol of the fibromyalgia trial is, and it should be underway if the last update we've seen from the company is true as best I remember.
In many ways, OWCP is like that iceberg often seen in photos where so little can be seen, but so much exists below the water where it's invisible to practically everyone.
Gary
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