I used "delay" because they have difficulty analyzeing rezults of the BDNF-ALS trial. Regeneron stated in last 10-Q report that some of enrolled patients are on RiluterTM during trial, and this patients must be analized separately or not at all. Amgen wants this patients included in overal account.
Even, if the results are positive, P-III can be compromised through the inclusion of these patients, and another P-III trials has to be undertaken. And, this will be realy delay!
Second, in P-I NT-3 trial two patients (2/76) develop liver-function abnormality on short term terapy. Great posibility is that at long term terapy more patient will develop same simptoms. If this is a case, trial has to be halted or altered.
I don't have any new news on this uncertanity!
Good things about Regeneron : 90% of expenses are for R&D, strong research program, three new alliance (Medtronic, PCOP, and PG), manufacture contract with Merck, and good cash position.
With the uncertanity in overal market performance, even light positive news(like IDPH, GILD or NRGN) can trigger sell-of. I hope, this is not a case for REGN!
Good luck.
Miljenko |
