I would guess late '06 or into '07. PG and Curis both have been able to produce the same results. This means that the method of regrowing hair is valid. Hence there is no bias in the technique of the protocol. During the presentations curis seems happy and upbeat about the collaboration with PG. They just need to prove to the FDA that there is no abnormal cellular growth, and that they can only target hair cells. This largely depends on the agonist of choice and the cream formulation.

I just listened to the new curis updates. It seems like they will be filing the the hair IND sometime in '07.


To listen to the presentation go to curis.com or
http://phx.corporate-ir.net/phoenix.zhtml?c=123198&p=irol-irhome

Sounds like good news. Maybe we'll see it come to the market in 2010 or so.

I'm bad with acronyms. What does IND stand for, and what is the time line for this aspect of the approval process?

Thanks.

IND = Investigational New Drug (IND)

What will happen is P&G will file a lot of paper work to the FDA. THe preclinical science must met certain FDA standards. If the paper work / science does then the FDA will accept the IND and say you can start Phase 1 clinical trials.

To read more about the IND process read here:

http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

For the latest press pdf from curis website

• 1st preclinical development objective
  reached; $1.0 M cash payment received (already received)
  
  
• 2nd preclinical development objective
  based upon lead candidate selection
  Expected Q1 2007; $1.8M cash payment
  
  
• IND filing anticipated within 12 months of
  lead selection
  
  
• IND will trigger cash milestone or Curis may
  elect to co-develop from IND to end of Ph II to
  receive higher royalty on net sales