Moxa, The reality is that OWCP could do what I
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Posted On: 07/27/2017 3:04:11 PM
Moxa,
The reality is that OWCP could do what I described in the same way that tiny biotechs have done it, in some cases with even less in financing then we currently have. I'm not advocating this, I would like the company to clearly say they'll market product with less than full drug approvals in the countries, or states they're marketing in.
You're right about what they'd need to do, but many tiny biotech's have taken similar actions to get products through the full approval process. Sadly in the end, those companies only get pennies on the dollar, but they survive to build the company further.
OWCP has clearly stated they don't intend to supply products all over the world. One option would be licensing one or more product to a big Pharma for potentially hundreds of millions up front. That money would certainly buoy the stock, but it would also put the decision on whether to treat products as a drug, delaying it's sales for years, or treating it as a cosmetic or nutraceutical that could be marketed almost immediately.
I certainly cannot say what the company will do. I would prefer them keeping the lion's share of sales by getting sales going ASAP by forming regional partnerships like Mediq, and being willing to market cosmetic's and/or nutraceutical's rather than taking what I believe would be years to achieve the status of being approved drugs. I'm certain that in many countries they can do it faster than here in the U.S., but I don't believe that both trials, and the approval process is possible anywhere in the major drug markets in under a year. I'd certainly welcome anyone to show me how in Germany, or anywhere else the process can be done in months.
I believe we need a clear statement from the company, without it, we simply speculate indefinitely. Even Mediq could clear this up if they published their plan for marketing the drug in Germany, but a few people calling them isn't a statement of what they're intending to do.
The fact that our product is market ready is meaningful, even if we're not marketing it today. Another interpretation of market ready is that the product is of the quality needed to do a pivotal trial. A Phase 2 Trial can be approvable if the trial is done with pivotal quality material, and results are so great that the approval authorities are willing to take a look. I know the U.S. FDA takes at least 6 months, and may take one year after the submission of an NDA or BLA which normally takes months to prepare after a trial ends. Other govt. agencies may certainly move faster, but I doubt if it can happen in under 3 months after a submission that's the equal of an NDA or BLA here.
Frankly we've only heard that Mediq intends to run some additional trials, we don't know if the cost of the trials will be paid for by Mediq, by OWCP, or by some other combination of funds, or perhaps even from a grant from some agency. Nothing has been clearly explained because everything is based on a few phone calls, nothing more.
Gary
The reality is that OWCP could do what I described in the same way that tiny biotechs have done it, in some cases with even less in financing then we currently have. I'm not advocating this, I would like the company to clearly say they'll market product with less than full drug approvals in the countries, or states they're marketing in.
You're right about what they'd need to do, but many tiny biotech's have taken similar actions to get products through the full approval process. Sadly in the end, those companies only get pennies on the dollar, but they survive to build the company further.
OWCP has clearly stated they don't intend to supply products all over the world. One option would be licensing one or more product to a big Pharma for potentially hundreds of millions up front. That money would certainly buoy the stock, but it would also put the decision on whether to treat products as a drug, delaying it's sales for years, or treating it as a cosmetic or nutraceutical that could be marketed almost immediately.
I certainly cannot say what the company will do. I would prefer them keeping the lion's share of sales by getting sales going ASAP by forming regional partnerships like Mediq, and being willing to market cosmetic's and/or nutraceutical's rather than taking what I believe would be years to achieve the status of being approved drugs. I'm certain that in many countries they can do it faster than here in the U.S., but I don't believe that both trials, and the approval process is possible anywhere in the major drug markets in under a year. I'd certainly welcome anyone to show me how in Germany, or anywhere else the process can be done in months.
I believe we need a clear statement from the company, without it, we simply speculate indefinitely. Even Mediq could clear this up if they published their plan for marketing the drug in Germany, but a few people calling them isn't a statement of what they're intending to do.
The fact that our product is market ready is meaningful, even if we're not marketing it today. Another interpretation of market ready is that the product is of the quality needed to do a pivotal trial. A Phase 2 Trial can be approvable if the trial is done with pivotal quality material, and results are so great that the approval authorities are willing to take a look. I know the U.S. FDA takes at least 6 months, and may take one year after the submission of an NDA or BLA which normally takes months to prepare after a trial ends. Other govt. agencies may certainly move faster, but I doubt if it can happen in under 3 months after a submission that's the equal of an NDA or BLA here.
Frankly we've only heard that Mediq intends to run some additional trials, we don't know if the cost of the trials will be paid for by Mediq, by OWCP, or by some other combination of funds, or perhaps even from a grant from some agency. Nothing has been clearly explained because everything is based on a few phone calls, nothing more.
Gary
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