I certainly don't know if we've hit bottom, or not
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Posted On: 07/13/2018 5:58:45 PM
I certainly don't know if we've hit bottom, or not, but I still believe that behind the scenes a lot is happening at OWCP. Most biotechs work on advancing one or two products to market, and have others following behind. We know that OWCP is planning to have at least three products in the clinic shortly, the psoriasis cream is about to start Phase 2, the nasal spray and sublingual tablets are approaching Phase 1, if they're not in it already. All three could easily be into Phase 2's together, especially if the new trials are actually designed as Phase 1/2 Trials.
I cannot say when they'll tell us more, I suspect they want to announce something big, and they're working on it, but I certainly don't know. I also don't know if approval anywhere can occur from out of a Phase 2 Trial if results really look outstanding unless the trial is originally designed for potential approval. If this were an FDA approved trial, such a trial would have to be done double blinded with a control group, and with the drug made with pivotal quality material. I believe in the case of our psoriasis cream and sublingual tablets we already may be using commercial quality materials based on the market ready statements from the company, I don't know about the nasal spray.
If approval out of Phase 2 is possible, we might be looking at approvals somewhere next year. I don't know what countries might apply to this effort, but Israel would certainly seem like a possibility. If that's not possible, Phase 3 Trials would take approval well into the 2020's depending on the size of the trial. Phase 2 might be International, Phase 3 almost certainly would be, and I would hope the U.S. was part of the mix.
The question that still needs to be answered by the company is at what point do they consider marketing the products as cosmetics/nutraceuticals, which they originally had indicated they would, or have we evolved into a pure biotech, but not been told that was the case. It's my belief that it hasn't happened and they will market product once it has exhibited both safety and some degree of efficacy, but nothing like what is required for approval. An unblinded Phase 2, or possibly even a Phase 1 done with conditions that the products were designed for might prove the product effective enough to market.
As always, JMHO.
Gary
I cannot say when they'll tell us more, I suspect they want to announce something big, and they're working on it, but I certainly don't know. I also don't know if approval anywhere can occur from out of a Phase 2 Trial if results really look outstanding unless the trial is originally designed for potential approval. If this were an FDA approved trial, such a trial would have to be done double blinded with a control group, and with the drug made with pivotal quality material. I believe in the case of our psoriasis cream and sublingual tablets we already may be using commercial quality materials based on the market ready statements from the company, I don't know about the nasal spray.
If approval out of Phase 2 is possible, we might be looking at approvals somewhere next year. I don't know what countries might apply to this effort, but Israel would certainly seem like a possibility. If that's not possible, Phase 3 Trials would take approval well into the 2020's depending on the size of the trial. Phase 2 might be International, Phase 3 almost certainly would be, and I would hope the U.S. was part of the mix.
The question that still needs to be answered by the company is at what point do they consider marketing the products as cosmetics/nutraceuticals, which they originally had indicated they would, or have we evolved into a pure biotech, but not been told that was the case. It's my belief that it hasn't happened and they will market product once it has exhibited both safety and some degree of efficacy, but nothing like what is required for approval. An unblinded Phase 2, or possibly even a Phase 1 done with conditions that the products were designed for might prove the product effective enough to market.
As always, JMHO.
Gary
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