I believe that many companies believe the same thi
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Posted On: 04/15/2019 2:39:28 PM
I believe that many companies believe the same thing, but in reality their competitors know what they're doing, they're only hiding information from their investors. If they gain the patents, competitors would be forced to do things differently, or pay for rights to use their patents. Without the patents, I cannot see raising the funds needed to run Phase 3 trials, and only tiny Phase 2 could be justified.
By the way, most of my investment history has been with oncology products, and at least in that case, Phase 1 Trials were all run with patients with refractory disease. In that these were escalating dose trials, patients early in the trial knew the drug would have little chance for them, but often once shown safe at higher doses, early patients could get further dosing.
I just spoke with the PR person at another company. Among other things he told me of their planned Phase 2 which the FDA seems to be supporting which will not be blinded, nor will it have a control group. It seems the FDA is recognizing that the historical background is sufficient to compare with results from a trial where all see the benefits of being on the drug. I believe the future will hold a lot more drugs being approved out of Phase 2's developed in this manner.
Gary
By the way, most of my investment history has been with oncology products, and at least in that case, Phase 1 Trials were all run with patients with refractory disease. In that these were escalating dose trials, patients early in the trial knew the drug would have little chance for them, but often once shown safe at higher doses, early patients could get further dosing.
I just spoke with the PR person at another company. Among other things he told me of their planned Phase 2 which the FDA seems to be supporting which will not be blinded, nor will it have a control group. It seems the FDA is recognizing that the historical background is sufficient to compare with results from a trial where all see the benefits of being on the drug. I believe the future will hold a lot more drugs being approved out of Phase 2's developed in this manner.
Gary
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