By SEC rules the company must report quarterly as well as reporting material events when they occur. The definition of what constitutes a material event seem to vary dramatically, depending on who's opinion you're listening to, as well as the size of the company. In a small company, a payment of a hundred thousand dollars might be considered material, whereas a larger company might not report a $5 million milestone being paid until the report quarterly events, in short, it's largely up to the company what's considered material.
The same thing is largely true of what is reported regarding clinical trials. For many companies Phase 1 or 2 Trials are often not reported on, unless they really wish to highlight the findings. Of course this is the approach a big Pharma will take, while tiny biotech's certainly like to discuss successes. In practically every case, failures if reported at all are reported in the clinical trials database by the trial being terminated, or simply a Phase 1 trial is completed, and no further trial is scheduled for the drug. It's rather like the expression that Old Soldiers never die, they simply fade away.
Our trial was never reported as starting in the Clinical Trials database, it was understood that the company took the attitude that in that the trial was not being done here, they would not update the database. One might ask why with that attitude they put it into the database in the first place if they never intended to update what was there.
I do believe we'll ultimately learn the findings of the trial, but I'm completely uncertain as to when, because we've been given no guidance on how much they are expanding the trial. I'm not suggesting this could happen, I do not know anything about Israeli approvals, but what if the clinicians running the trial in communications with Israeli authorities determined that if say 50 patients with the skin disease added to the trial that demonstrated efficacy were added to the trial, approval by Israeli authorities was possible if the data remained consistently positive. Again, I'm not suggesting this is happening, just indicating we've been given no official notification that the trial was even expanded to people with skin diseases. Is it possible in Israel to just keep expanding a Phase 1 trial until you actually can approve a drug, while I cannot see that happening if you aren't using pivotal quality drugs, we are in fact using commercial quality, which is actually one step higher.
In some countries, it's probably still possible to gain drug approvals by simply applying for it with practically no proof. I believe Israel is far more rigorous than that, but I also believe they're far more streamlined than our FDA who takes 6 months to a year to determine how to properly hard boil eggs. In short, I don't know that if authorities could actually look and speak with say 50 psoriasis patients and look at pictures before and after, if in speaking with these patients they heard of no unacceptable side effects, I don't know that these authorities couldn't say the product is approved. Our FDA by comparison would probably insist on trials going into the hundreds of patients, and the last thing I believe they'd ever do is speak with the patients who were treated.
I may be very wrong about how dynamic the Israeli authorities are, but not about how fixed the ways our FDA operates. They have rules that govern the whole process and rarely act to expedite approval for something with very obvious improvement on current therapies. Priority review by them is a 6 months process, while most experts with an hour to review the technical information gathered in the trials could say this is a product worthy of approving.
Gary
The same thing is largely true of what is reported regarding clinical trials. For many companies Phase 1 or 2 Trials are often not reported on, unless they really wish to highlight the findings. Of course this is the approach a big Pharma will take, while tiny biotech's certainly like to discuss successes. In practically every case, failures if reported at all are reported in the clinical trials database by the trial being terminated, or simply a Phase 1 trial is completed, and no further trial is scheduled for the drug. It's rather like the expression that Old Soldiers never die, they simply fade away.
Our trial was never reported as starting in the Clinical Trials database, it was understood that the company took the attitude that in that the trial was not being done here, they would not update the database. One might ask why with that attitude they put it into the database in the first place if they never intended to update what was there.
I do believe we'll ultimately learn the findings of the trial, but I'm completely uncertain as to when, because we've been given no guidance on how much they are expanding the trial. I'm not suggesting this could happen, I do not know anything about Israeli approvals, but what if the clinicians running the trial in communications with Israeli authorities determined that if say 50 patients with the skin disease added to the trial that demonstrated efficacy were added to the trial, approval by Israeli authorities was possible if the data remained consistently positive. Again, I'm not suggesting this is happening, just indicating we've been given no official notification that the trial was even expanded to people with skin diseases. Is it possible in Israel to just keep expanding a Phase 1 trial until you actually can approve a drug, while I cannot see that happening if you aren't using pivotal quality drugs, we are in fact using commercial quality, which is actually one step higher.
In some countries, it's probably still possible to gain drug approvals by simply applying for it with practically no proof. I believe Israel is far more rigorous than that, but I also believe they're far more streamlined than our FDA who takes 6 months to a year to determine how to properly hard boil eggs. In short, I don't know that if authorities could actually look and speak with say 50 psoriasis patients and look at pictures before and after, if in speaking with these patients they heard of no unacceptable side effects, I don't know that these authorities couldn't say the product is approved. Our FDA by comparison would probably insist on trials going into the hundreds of patients, and the last thing I believe they'd ever do is speak with the patients who were treated.
I may be very wrong about how dynamic the Israeli authorities are, but not about how fixed the ways our FDA operates. They have rules that govern the whole process and rarely act to expedite approval for something with very obvious improvement on current therapies. Priority review by them is a 6 months process, while most experts with an hour to review the technical information gathered in the trials could say this is a product worthy of approving.
Gary
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