Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Spectrum voluntarily withdraws/to resubmit a revised BLA for Rolontis.

One of the possible reasons why the Rolontis BLA filing was pushed to the end of December was due to the 12m safety data to mature but by waiting till Dec that was taken case of. One of my concerns prior to that was in having an accurate ID test method for GCSF. After all, that was the bane of Coherus' biosimilar of Neulasta where they got a CRL for their testing methods. From today's PR

Spectrum’s decision to withdraw the BLA was the result of the company needing more time to provide certain additional manufacturing-related information

it looks like that is the most likely suspect to me. At the last quarterly CC, what caught my eye was KG mentioning

We expect R&D costs to be nominally higher than it was last year as lower spend on the legacy assets is offset by increased spending on pre-commercial supply and tech transfer activities for both ROLONTIS and poziotinib

which can be a very normal thing but I now also suspect it had something to do w manufacturing info they needed to provide the FDA. I'm still waiting for Godot to arrive.
http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-provides-bla-filing-update-rolontisr