Personally I'd resist that impulse to break even,
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Posted On: 08/23/2018 6:51:26 PM
Re: LeaveMeAlone #13637
Personally I'd resist that impulse to break even, some of the biggest gains I've ever seen came after many investors I knew bailed out because they were essentially break even, sometimes after many years.
I believe in the company, though I may not agree with all its actions. I'm impressed by the personnel there and I believe they know enough about the products they have in development to be reasonably certain they'll be effective. It's one thing to know it, and another to prove it to the likes of the FDA.
I like psoriasis as an easy disease to demonstrate proof of concept with, it's easy to view and before and after photographs should certainly be easy to interpret.
It may not be as easy with things like PTSD, autism, etc but a change in personality over time should certainly be observable for experts in the field. I believe that most Doctors could also judge improvements for patients with fibromyalgia. Unlike oncology trials where survival or drug progression might be observed over years, I believe in many cases our drugs will have improvements that can be seen in weeks, but regulators will probably insist on at least 2 or 3 months of data for each patient in the trial, but that's still relatively quickly.
As of now it appears that the company intends to do it's trials in one or a few Israeli hospitals. While I believe they do excellent work, if they did have a deep pockets partner, I believe these trials would be spread out to many countries, and they could be done much faster as it's far easier to find say 3 patients per trial site and have 100 sites, than having 3 sites which each must enroll 100 people. One site is fine for small Phase 1's, but with larger trials we really should be in more sites, and multinational as well.
Gary
I believe in the company, though I may not agree with all its actions. I'm impressed by the personnel there and I believe they know enough about the products they have in development to be reasonably certain they'll be effective. It's one thing to know it, and another to prove it to the likes of the FDA.
I like psoriasis as an easy disease to demonstrate proof of concept with, it's easy to view and before and after photographs should certainly be easy to interpret.
It may not be as easy with things like PTSD, autism, etc but a change in personality over time should certainly be observable for experts in the field. I believe that most Doctors could also judge improvements for patients with fibromyalgia. Unlike oncology trials where survival or drug progression might be observed over years, I believe in many cases our drugs will have improvements that can be seen in weeks, but regulators will probably insist on at least 2 or 3 months of data for each patient in the trial, but that's still relatively quickly.
As of now it appears that the company intends to do it's trials in one or a few Israeli hospitals. While I believe they do excellent work, if they did have a deep pockets partner, I believe these trials would be spread out to many countries, and they could be done much faster as it's far easier to find say 3 patients per trial site and have 100 sites, than having 3 sites which each must enroll 100 people. One site is fine for small Phase 1's, but with larger trials we really should be in more sites, and multinational as well.
Gary
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