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Just a few readers just lately talked about that Follica’s homepage has gone darkish. It now solely shows a emblem and call e-mail. You can undergo my Follica class part to see the quite a few instances that I coated this firm up to now. Unfortunately, as was the case with Histogen, Samumed and Replicel, a decade of protection has come to naught.

Follica Logo

Note that Follica was based all the way in which again in 2005. In 2019, they lastly appeared near starting Phase 3 trials for his or her wounding (aka microneedling) gadget. With the addition of Minoxidil and different proprietary compounds. Even as just lately as 2022, the corporate’s CEO Jason Bhardwaj sounded very optimistic.

The following quote (credited to Dr. George Cotsarelis) from the previous Follica web site was very motivating (because it meant an nearly pure hair regrowth therapy):

“Following skin disruption, cells that migrate to help healing are forced to make a decision: Should I make epidermis, or should I make a hair? There is a window of opportunity in which we can potentially push them to choose the latter, and we believe there are multiple biological pathways to target to enhance this outcome. This regenerative effect is called hair follicle neogenesis.”

Follica Goes Into Hibernation

I used to be not planning to write down this submit till a reader e-mailed me a just lately uploaded 2022 Annual Report from PureTech Health (majority proprietor of Follica). In there are some attention-grabbing statements, probably the most related of which is as follows:

“With an increased focus on resource allocation towards our Wholly Owned Programs, we decided to hibernate the Follica Founded Entity in the 2023 post-period. We may choose to advance this program at a later date or with partners.”

Note that different corporations equivalent to OrganTech and Follicum have just lately come again from the lifeless for second makes an attempt. I really feel like Follica will possible come again, though maybe in a rustic with extra favorable laws than the US (per the under elaboration)?

Cumbersome US Regulatory Process to Blame?

Note that the above talked about Annual Report breaks out intimately the quite a few challenges that PureTech/Follica confronted with the US authorities regulatory course of. It does appear unusual that PureTech is mentioning these points so late within the recreation, particularly since they may have no less than tried to carry their gadget to market with simply Minoxidil. I’m assuming their drug contained extra than simply Minoxidil (a debate we had for a few years).

Below, I’m pasting all the assertion from web page 183 of the Annual Report:

“The complexity of a combination therapeutic that includes a drug or biologic and a medical device presents additional, unique development and regulatory challenges, which may adversely impact our or our Founded Entities’ development plans and our or our Founded Entities’ ability to obtain regulatory clearance, authorization or approval of our Wholly Owned Programs or our Founded Entities’ therapeutic candidates.

We or our Founded Entities, such as Follica, may decide to pursue marketing authorization of a combination therapeutic. A combination therapeutic may include, amongst other possibilities, any investigational drug, device, or biologic packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biologic where both are required to achieve the intended use, indication, or effect.

Developing and obtaining regulatory clearance, authorization or approval for combination therapeutics pose unique challenges because they involve components that are regulated by the FDA under different types of regulatory requirements, and by different FDA centers. As a result, such therapeutics raise regulatory, policy and review management challenges.

For example, because divisions from both FDA’s Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research and FDA’s Center for Devices and Radiological Health must review submissions concerning therapeutic candidates that are combination therapeutics comprised of drug or biologics and devices, respectively, the regulatory review and clearance, authorization or approval process for these therapeutics may be lengthened.

In addition, differences in regulatory pathways for each component of a combination therapeutic can impact the regulatory processes for all aspects of therapeutic development and management, including clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, user fees and post-clearance, authorization or approval modifications.

Similarly, if applicable, the device components of a combination therapeutic candidate will require any necessary clearances, certifications or approvals or other marketing authorizations in other jurisdictions, which may prove challenging to obtain.”

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