GTC Biotherapeutics (fka GTCB)

[wjlknew]

Related, from Pharming's 2007 Annual Report released February 15th:

"In interactions with the FDA throughout 2007, no questions appeared to be outstanding with regard to the use of human lactoferrin in nutritional products. The GRAS-notification has been reviewed by an independent scientific expert panel who agreed that hLF is safe for its intended uses. Although Pharming had expected to receive a decision from the FDA in 2007, it is still hopeful that the agency will accept Pharming’s notification in the near future."

Pharming has solidified its position in the production of human lactoferin. All they need now is FDA notification of GRAS.

It seems Pharming and GTCB both experienced unexpected delays toward the end of 2007. GTCB's anticipated partner agreement and HD trial completion did not materialize. Pharming did not receive the GRAS notification, but did receive a negative opinion from the CHMP regarding Rhucin ... which has been appealed. However, both GTCB and Pharming expect to have the delays worked out "in the not too distant future" and "in the near future", respectively.

That would be nice.