John, my sense is that AGPH isn't interested at this point in committing the huge amount of capital for a manufacturing facility, and will continue to toll manufacture Nelf. At a summer meeting, two AGPH chemists mentioned they have four separate manufacturers making Nelf for them. Since 80% of clinical candidates fail to come to market (industry average), my guess would be that they're hiring for the front end, early scale up work; cGMP is important throughout the development life of a compound, as all studies going in to an IND - tox, formulation, stability, analysis, and ultimately, the clinical trials, must be done with cGMP manufactured material. For those numbing over already, cGMP stands for current good manufacturing procedure, a set of protocols for running chemical reactions, cleaning and validating the cleanliness of reactors used communally for different compounds, and the documentation in support of the protocols.
Sad to see that AGPH was one of the few dips in my portfolio yesterday. When its good its good, and when its bad its pretty bad.
The stock, that is :-)
Regards,
Randy |
