- Reaction score
- 460
Correct.
Puretech Health - 2017 Annual Report (2018-04-16)
- Thread starter Noisette
- Start date
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- Tags
- follica puretech health
So, the Western and EU have Follica and the Asia has Shiseido.
- Reaction score
- 460
Not really.
Follica would be available only in the U.S.
Shiseido in East and Southeast Asia.
Seems like they extended / delayed optimization study. We here all assumed they finished the optimization study.
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- 123
LOL. "Significant progress", "optimization study", ... Who is even buying this bs?
Does it really take months and months to optimize a couple of parametres to administer wounding + topical treatment?
Unless you are heavily biased, these guys are more ridiculous than brotzu.
Does it really take months and months to optimize a couple of parametres to administer wounding + topical treatment?
Unless you are heavily biased, these guys are more ridiculous than brotzu.
H
Senior Member
- Reaction score
- 775
Now the Follica cult will inform you how "everyone who doubts Follica is ignorant and stupid" I've gotten the brochure plenty of times.
You know what. In 2017 everyone thought that it will launch in March, just like Brotzu, because they had the packages.
sh*t, the optimisation study is longer than we thought. But they never talked about the duration of the study.
So, Pivotal is scheduled to start first half next year testing FDA approved drugs with a new device, which means a different (significantly shorter) approval process.
I think the release date of RAIN will be very close to Samumed WNT agonist.
So, Pivotal is scheduled to start first half next year testing FDA approved drugs with a new device, which means a different (significantly shorter) approval process.
I think the release date of RAIN will be very close to Samumed WNT agonist.
Why should the FDA process be much shorter ?
Because they will pursue "FDA Clearence" instead of the classic drug approval pathway:
https://www.fda.gov/medicaldevices/...ures/deviceapprovalsandclearances/default.htm
- Reaction score
- 967
Follica = Device + Compound. So, the FDA clearance is meant for the device, then the compound is drug, which need to follow drug pathway. They need approval for both drug and device in order to release it to the market, right ?
@alibaba92 They stated several times that the first iteration of the treatment consist of FDA approved drugs (minoxidil, and something else) and the device, thats why the optimistic timeline.
They are doing preclinical testings to develop new chemical entities. Thats why Follica is so exciting, they are investing good money to keep advancing their concept: skin disruption & effective growth stims.
H
Senior Member
- Reaction score
- 775
Just browsing
Does anybody know if this would be available in Europe too eventually? The application shouldn't be any different than for FDA and most pharma usually apply at the same time.
Also it is true that if they use Minoxidil they wouldn't need new trials but if they try different % or a mix of things they might have to perform additional trials.
Also it is true that if they use Minoxidil they wouldn't need new trials but if they try different % or a mix of things they might have to perform additional trials.