Replies to post #185628 on Biotech Values

[bladerunner1717]

CHRS up 18% today on this news.

Bladerunner

[DewDiligence]

ODAC endorses NVS’ Neupogen FoB by 14-0 vote:

http://t.co/IKzBOHu04q

This one was never in doubt.

[DewDiligence]

Neupogen FoB addendum: ODAC not only unanimously endorsed NVS’ FoB for FDA approval, but also opined that the FoB should be approved for all five of Neupogen’s approved indications:

• Cancer Patients Receiving Myelosuppressive Chemotherapy
• Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
• Cancer Patients Receiving Bone Marrow Transplant
• Patients Undergoing Peripheral Blood Progenitor Cell Collection and Therapy
• Patients With Severe Chronic Neutropenia

The ability to gain FDA approval for multiple indications in one fell swoop is a major advantage of the 351(k) regulatory pathway. If NVS had instead used the conventional BLA pathway for its Neupogen FoB, it would probably have had to conduct one or more phase-3 trials in each of the above indications.

[DewDiligence]

CHRS says it can start one phase-3 FoB trial every 2 years. (Source: JPM webcast.) I’m somewhat skeptical they can do that.