"Zohar says Follica has further developed this work and filed additional patents to protect the technology. What’s so beautiful about the approach, she says, is that translating it into a treatment for humans involves only devices and drugs that are already on the market. A doctor would first use a microdermabrasion tool, say, or a laser to remove the top layers of the skin—as is already commonly done in a number of dermatologic and cosmetic procedures—knocking some cells back into a primitive state. The doctor can then use this newly created therapeutic window to inject drugs that push the cells to develop along one pathway or another and grow hair or skin. Zohar won’t reveal what drugs Follica is using, except to say that they are small molecule drugs normally taken orally for purposes with no relation to hair growth.
Because the components of the system are already approved, the regulatory path is pretty straightforward, and Follica can perform human studies without jumping through a lot of governmental hoops. That’s exactly what the company plans to do with the money it has just raised. "
Breakdown of italics (in order):
I think there she hinted herself that there is a good chance they may not require trials or skip certain trials - why else would she say “What’s so beautiful…already on the market”?
Remote the top layers, so guys planning on going deep - Don’t! their patent also mentions “Stratum Corneum” which is the top most layer of the skin. No need to go any deep and btw seeing blood is deep w.r.t. Follica procedure. Also in their research study, they would be doing gentle abrasion.
Apparently they are Injecting drugs - that’s the first!
Small molecule drug normally taken orally = gefitinib
Another possible hint at the fact they may not need to go through extensive trials
“Other reasons for performing trials at this stage include attempts by the sponsor at “label expansion” (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug”
I think they may need to go through a small phase-II trial and then onto phase-III. and during the phase-III it probably would be available to people as well. This from the same page:
“Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines”
means that they can do human research without FDA aproval.
I’m not convinced though that they will just start selling gefinitib based solution. This wont hapen unless they would license gefinitib from its current owner.
» I’m buying if there is a source.
»
» anyway
»
» 1) means that they can do human research without FDA aproval.
»
» I’m not convinced though that they will just start selling gefinitib based
» solution. This wont hapen unless they would license gefinitib from its
» current owner.
Why do they need to license it? It’s a product that is already being sold in the market. They can just buy it, use it in their own compound and sell the procedure. They only reason they need to license gefitinib is if they were creating a clone of it/generic version, but they aren’t! so no licensing.
We are also not sure if they are going with gefinitib, they may use some other EGF inhibitor. Also, they will be administering it for few days at most, so that makes it much safer and accordingly the restrictions would be less.
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