Replies to post #6622 on GTC Biotherapeutics (fka GTCB)

[jessellivermore]

"Don't forget GE"

GG. Guess this is meant as a tongue in cheek comment, I've already heard from one doubting ThomasS. Guess my message is not very clear. Like most everyone else on the board I understand GTCG's protein production platform (its NPPS) is superior to cell culture production in terms of cost of production and it's ability to produce certain protiens,eg plasma proteins and MABs in higher quanity.

Initial speculation was large pharmaceutical companies (BP) would understand these advantages and form agreements of different sorts with GTCB to produce proteins. This would produce revenues for GTCB. That this has not happened is beyond debate. This despite the fact GTCB has a transgenically produce product which has been approved by a major regulatory agency, the EMEA. BP does not need the "rubber stamp" approval of the FDA to understand this technology is not only real,,,it is the future. But this is not the problem. At present regardless of the preceived advantages of GTCB's NPPS there is no economic incentive for BP to switch over to transgenics. From a financial standpoint shortening the time it takes to get through the regulatory trials is more important than all other factors. That includes factors such as cost of production or quanity of yeild. The facts are cell culture is faster. This combined with the FDA insistence that the protein sold must be made, eg by cell culture, by the same method of the protein that was created for the trials. If it is made by a different technique,eg transgenics the FDA would consider it a different drug which would have to go thru a completely new set of trials.

Will the above situation change. Probably, right now patients are denied medical treatment from critical shortages and exorbidant prices which are created by supply and demand brought on by using production platforms,eg cell culture which BP knows will not produce enough product.

It may well be better for GTCB (the shining star of NPPS companies) to partner with a company like DuPont or Monanto who are one step away from big pharma. They have the stature and the power to get some of these much needed changes rolling.

more to follow