I'll be 80 then, but I'm willing to wait. The p
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Posted On: 07/26/2018 2:23:40 PM
I'll be 80 then, but I'm willing to wait.
The price is down because the reality that product won't be sold for awhile has finally been solidified by the company. It was Zev who was telling everyone who'd listen that it was only a matter of months away, and perhaps it would have been had he not been fired, but the product at that point wouldn't have even been proven safe, forget effective. That's not the action of a company that describes itself as a cannabis based biotech.
Hirsch has not completely eliminated the possibility of marketing products before full drug approval is achieved, but he has stated that efficacy for products must be established, as well as safety, which always comes first.
I still believe the first thing that needs to happen is patent approvals for any product they'd consider bringing to market. That could come anytime from now till after efficacy is seen in a Phase 2 Trial, but I don't believe they'd consider going into the costs of running a Phase 3 without knowing they had patent coverage for the drug. Likewise, even if the drug demonstrates efficacy in Phase 2, they'd want patent coverage before bringing it on the market IMHO.
Last year I sold some shares for a tax loss, then bought back more than I sold. I don't know where the bottom will be with the current atmosphere, but I'm planning to acquire shares when I sense it's been reached so I can sell my higher priced shares for a long term loss at the end of the year. If we get some big surprise, which is possible with patent approvals and perhaps a partnership, I might just keep all the shares, but if not, at least I'm lowering my base.
As for the company, I believe they're doing what they can, they're developing new products and putting them into early stage trials at very low cost. Certainly, their methods don't bring drugs to approval as fast as if they had unlimited resources, but once they have patent approval and demonstrated efficacy, I believe they'll gain financial resources to run expansive Phase 3 Trials from partnerships that will certainly rally the stock dramatically. The potential for that could certainly occur by late next year depending on how the Phase 2 Trials are structured, and of course the actions of those granting patent approval. Frankly, even the Phase 2 Trials are only partially in the company's control, they must deal with regulators and the IRB who may, or may not accept the protocol suggested by the company, some negotiations may get them some gains, but largely they must live with what these people insist on before the trial is initiated. If you look at the Phase 1 protocol that was posted in the clinical trials database years ago, it said nothing about a second series of multiple daily doses, it was all built into a single trial that was supposed to be over in a matter of months. I've got to believe that the changes were forced on them by the regulators, including the IRB. We learned nothing about it because they never updated the clinical trials filing.
Lets see if we start to get patent approvals shortly, if we do, I believe we'll have the basis for a move back up to levels we're at least break even or more, but I think we need that before we gain a partnership with anyone who's name would be recognized as someone with the deep pockets needed to bring drugs to the marketplace.
Gary
The price is down because the reality that product won't be sold for awhile has finally been solidified by the company. It was Zev who was telling everyone who'd listen that it was only a matter of months away, and perhaps it would have been had he not been fired, but the product at that point wouldn't have even been proven safe, forget effective. That's not the action of a company that describes itself as a cannabis based biotech.
Hirsch has not completely eliminated the possibility of marketing products before full drug approval is achieved, but he has stated that efficacy for products must be established, as well as safety, which always comes first.
I still believe the first thing that needs to happen is patent approvals for any product they'd consider bringing to market. That could come anytime from now till after efficacy is seen in a Phase 2 Trial, but I don't believe they'd consider going into the costs of running a Phase 3 without knowing they had patent coverage for the drug. Likewise, even if the drug demonstrates efficacy in Phase 2, they'd want patent coverage before bringing it on the market IMHO.
Last year I sold some shares for a tax loss, then bought back more than I sold. I don't know where the bottom will be with the current atmosphere, but I'm planning to acquire shares when I sense it's been reached so I can sell my higher priced shares for a long term loss at the end of the year. If we get some big surprise, which is possible with patent approvals and perhaps a partnership, I might just keep all the shares, but if not, at least I'm lowering my base.
As for the company, I believe they're doing what they can, they're developing new products and putting them into early stage trials at very low cost. Certainly, their methods don't bring drugs to approval as fast as if they had unlimited resources, but once they have patent approval and demonstrated efficacy, I believe they'll gain financial resources to run expansive Phase 3 Trials from partnerships that will certainly rally the stock dramatically. The potential for that could certainly occur by late next year depending on how the Phase 2 Trials are structured, and of course the actions of those granting patent approval. Frankly, even the Phase 2 Trials are only partially in the company's control, they must deal with regulators and the IRB who may, or may not accept the protocol suggested by the company, some negotiations may get them some gains, but largely they must live with what these people insist on before the trial is initiated. If you look at the Phase 1 protocol that was posted in the clinical trials database years ago, it said nothing about a second series of multiple daily doses, it was all built into a single trial that was supposed to be over in a matter of months. I've got to believe that the changes were forced on them by the regulators, including the IRB. We learned nothing about it because they never updated the clinical trials filing.
Lets see if we start to get patent approvals shortly, if we do, I believe we'll have the basis for a move back up to levels we're at least break even or more, but I think we need that before we gain a partnership with anyone who's name would be recognized as someone with the deep pockets needed to bring drugs to the marketplace.
Gary
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