Follica Phase 3?

[Penny Stock]

See below in red, looks like follica may be on it's way to Phase 3.


Definitions:
Impd: Investigational Medicinal Product Dossier
IND: Investigational New Drug Application
(CTM): Clinical Trial Materials Manufacturing
http://www.linkedin.com/pub/shikha-barman/3/55a/607

Shikha Barman's Experience
Vice President and Head, Pharmaceutical Development
Follica, Inc.
Privately Held; 1-10 employees; Biotechnology industry
January 2010 – Present (2 years 1 month)
RESPONSIBILITIES
1. Providing guidance in targeted Drug Delivery/Pharmaceutical Sciences for development of core IP; co-inventor in company IP; spearheading new targets; assisting in the selection of druggable compounds.
2. Responsible for the following departments: Preclinical and Clinical Pharmaceutical Sciences (CMC/Analytical/Formulations), Pharmacokinetics and Toxicology. Task allocation, task implementation and budget setting/management.
3. Cross-functional interface with Preclinical Biology and Clinical Development for company’s development program strategies in regenerative medicine, hair follicle neogenesis and new targets. Interfacing with CROs to implement various aspects of each program. Interfacing with experts/consultants to define regulatory/toxicology strategy; Interface with IP/BD for strategic development of company programs.
4. Responsible for CTM manufacturing/release for IND/IMPD submissions for Phase I/II/III programs; responsible for PK, Toxicology and CMC sections for IND submissions.
Senior Executive Director, Drug Development
Follica, Inc.
Privately Held; 1-10 employees; Biotechnology industry
February 2009 – March 2010 (1 year 2 months)
ACCOMPLISHMENTS
1. IMPD submission to German regulatory authority for initiation of a Phase II clinical trial in Androgenetic Alopecia (AGA) using company’s novel IP; co-drafted sections of CMC, toxicology and preclinical studies. Successfully co-ordinated clinical supplies/pharmacy operations in EU trial.
2. Co-inventor in multiple patent applications in hair growth, wound healing, scar reduction and cosmetics. Co-author in company publications in progress.

[Maradona]

Nice find.

However since follica doesn't release results or anything i don't think many people care here : ( . I do care about every treatment though.

Everybody is holding their breath for replicel right now we only have 2 months left and we will see if we will baldies for the rest of our lives or not.

Thanks for that mate, will investigate further : ) . Always feel better when progress is seen ; - 0 .

[krewel]

A potential solution entering Phase III is a pretty big deal, thank you for this nice find.

If Follica really is entering Phase III, their method must be working, otherwise it would not be possible for them for enter Phase III.

The only question is how effective their treatment is. Well, nobody knows. Maybe it's the holy grail, maybe its "just" a way better minoxidil, which would be totally ok.

Follica is financially on the safe side, so there is no point in investing into marketing yet, they don't even need marketing if they're finished with Phase III and their method works.
Replicel still has a veeeeery long way, 2015 will not work. Phase II always needs longer than anyone expects, just take a look at how much it took for Aderans to be at the end of Phase II.

[Thinning@30]

A new hair loss treatment entering Phase 3 clinical trials is good news. Nonetheless, don't Phase 3 trials take even longer than Phase 2? On other hand, isn't it possible at least in some cases to release treatments before the completion of Phase 3? I wish Follica would provide us with more information.

[NeedHairASAP]

A new hair loss treatment entering Phase 3 clinical trials is good news. Nonetheless, don't Phase 3 trials take even longer than Phase 2? On other hand, isn't it possible at least in some cases to release treatments before the completion of Phase 3? I wish Follica would provide us with more information.

I believe rogaine got out during phase 3


but I have no source for that

[S.W]

forgive me if I misunderstand. The description only says it is a responsibility. My take on this is like: when folica *will* go to phase 3, then this lady will do some work to make it go smoothly.

See below in red, looks like follica may be on it's way to Phase 3.

4. Responsible for CTM manufacturing/release for IND/IMPD submissions for Phase I/II/III programs; responsible for PK, Toxicology and CMC sections for IND submissions.

[clandestine]

forgive me if I misunderstand. The description only says it is a responsibility. My take on this is like: when folica *will* go to phase 3, then this lady will do some work to make it go smoothly.

Seconded. Probably best to take words at face value.

[Follicle Death Row]

Dang. Much ado about nothing. :(

[born]

so is follica in phase 3?

[young]

It sounds like she WOULD be responsible.

But it could mean they are planning for it now... And they expect it to. I don't know.. But I hope so :)