Reading Monty’s posts, I have found this document about ICX which is quite interesting to see things in perspective:
page 41, onwards.
Maybe the main problem is money after all. Lack of money.
The document, tells ICX’s roadmap:
-in phase II, they were going to try 3 different formulations.
-Then, If some of the 3 formulations worked, they would jump to Phase III
using the best formulation.
-If none of them worked, then they would expand phase II to try new formulations.
So they covered the possibility of failure for these 3 formulations, and they planned to try more formulations.
So even if all 3 formulations failed, they didn’t plan to stop the project!!!
Why are they stopping now, even if the preestimulation seems promising?? Well, the only explanation seems that there is a severe lack of money.
But if the problem is the lack of money, and the preestimulation is working ok, then why are they hiding the number of hairs?
I don’t know.
They also say, very important,:
The proposed Phase II study strategy seems appropriate given the uncertainty about optimal formulation, the need to generate safety data for the US IND, limitations regarding number of injections possible prior to scale up and the need to find the optimal clinical setting. The timings for the proposed Phase II study seem reasonable given that this is a highly motivated patient population, though the study(ies) will require longer if further formulations need to be evaluated or if further safety data is required for the IND.
Budget estimates to mid-2007 for the first 20 patients in the THATCH II trial
(£500k) are adequate. If recruitment of further patients is required for THATCH II there will be additional costs. No budget is yet available for the pivotal Phase III trial.
Small studies have been carried out to date in model systems with human female DPs and it is too early to say what their long term fate will be.
So this document states that ICX had budget only for 20 trialists in phase II
There was no budget for Phase III yet. And apparently no budget for an expanded phase II.
But in spite of this, they say that they had plans to set up a manufacturing facility in USA for 2009, ready for product launch.
Currently the product is manufactured at the Group’s Manchester facility. In the USA a anufacturing facility will be set up at the same location as that for ICX-PRO; this is lanned to become operational in 2009 in time for product launch.
So it seems clear that they initially planned to keep investing money in the project beyond phase II.
It seems that now, they can’t afford these projects.
I would say that it is fundamentally by lack of money.
Apparently, they have money but just for the skin products.
Well, if my new guessings are right, maybe we are lucky if they find someone to pay the bills.
But of course, this is a big setback.