I'm sure you're right @jc3303 but im a hopeful lad so could this notion please get buried by a few people so I get the message....cause I read things like this
http://replicel.com/recent_coverage...-early-commercialization-early-reimbursement/
specifically this part
"This law speeds therapeutics to market by allowing conditional marketing authorization. For example, Hall says, “A 20-person trial that shows safety and is predictive of efficacy is sufficient to get conditional approval for seven years, without needing placebo trials. Efficacy will be determined by the market. The new regulations dramatically change the pathway toward revenue.”
Which sounds like the Phase 1 study already done on RCH-01 that will (after Feb) prove safety and indicate efficacy, even though just a few paragraphs down it says
“Our understanding of the PMD Act is that the PMDA is looking for more than just a Phase 1-type analysis. It would like to see a record of safety and some meaningful evidence of therapeutic benefit,” Van Bokkelen says.
In effect, that means “The option of going to market is after a solid Phase 2 trial,” Kleinhaus concludes. “Meanwhile, post-commercialization and observational studies must be conducted.”
We are likely to see a meaningful increase in clinical trial activity in Japan as a result of this new framework,” Van Bokkelen says. Although the regulations don’t specify that trials must be conducted in Japan, the PMDA is clearly guiding sponsors toward running a clinical trial in Japan."
But just from the start of the second excerpt it sounds like these are just opinions and there may be some wiggle room- when he says "Our understanding of the PMD Act is that..." So if Shiseido did propose to whomever committee that safety has been proven wouldn't they- if they asked nicely- be allowed temporary approval of the treatment so has to help the market prove efficacy and drive up some revenue?
You see its the hopeful in me that ignores the second. So someone(s) please confirm for me that 2017 will just be a void used as a waiting room till I can get some treatment for my head. The more people the better.
http://replicel.com/recent_coverage...-early-commercialization-early-reimbursement/
specifically this part
"This law speeds therapeutics to market by allowing conditional marketing authorization. For example, Hall says, “A 20-person trial that shows safety and is predictive of efficacy is sufficient to get conditional approval for seven years, without needing placebo trials. Efficacy will be determined by the market. The new regulations dramatically change the pathway toward revenue.”
Which sounds like the Phase 1 study already done on RCH-01 that will (after Feb) prove safety and indicate efficacy, even though just a few paragraphs down it says
“Our understanding of the PMD Act is that the PMDA is looking for more than just a Phase 1-type analysis. It would like to see a record of safety and some meaningful evidence of therapeutic benefit,” Van Bokkelen says.
In effect, that means “The option of going to market is after a solid Phase 2 trial,” Kleinhaus concludes. “Meanwhile, post-commercialization and observational studies must be conducted.”
We are likely to see a meaningful increase in clinical trial activity in Japan as a result of this new framework,” Van Bokkelen says. Although the regulations don’t specify that trials must be conducted in Japan, the PMDA is clearly guiding sponsors toward running a clinical trial in Japan."
But just from the start of the second excerpt it sounds like these are just opinions and there may be some wiggle room- when he says "Our understanding of the PMD Act is that..." So if Shiseido did propose to whomever committee that safety has been proven wouldn't they- if they asked nicely- be allowed temporary approval of the treatment so has to help the market prove efficacy and drive up some revenue?
You see its the hopeful in me that ignores the second. So someone(s) please confirm for me that 2017 will just be a void used as a waiting room till I can get some treatment for my head. The more people the better.
