Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

ASH abstract 4149 Case Match Control Analysis of Propel Reveals Survival Advantage for Patients with Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) Treated with Pralatrexate

SPPI, in addition to having an inclusive PR listing all their abstracts at ASH 2016, separately PRd abstract 4149. Spectrums PR can be found here

http://investor.sppirx.com/releasedetail.cfm?ReleaseID=1002825

with the main highlight of the PR as

The overall survival observed in the control population was 4.04 months (95% CI 2.60, 6.01) which was consistent with historical controls, while the median OS in for pralatrexate treated cohort was 14.78 months (95% CI 10.61-22.31).

When you put it that way, it does seem pretty impressive. Will it help sell more drug? Well at a minimum it can’t hurt. Spectrum sales peeps should be able to present this abstract to the docs who will use this drug. Back in 2014, FDA Released a Guidance on Use of Scientific and Medical Literature for Promotional Purposes. A summary of the requirements on how to do so is summarized in this reference

FDA's guidance forms a checklist of sorts that companies will need to check against each instance of literature they wish to promote.
Scientific and medical journal articles, for example, should be from a peer-reviewed journal, be distributed in unabridged form (i.e. reprint), contain information from an "adequate and well-controlled clinical investigation" and be "scientifically sound."
In addition, the FDA-approved labeling should be disseminated along with the literature, as well as a comprehensive bibliography of information from other publications (including contradictory literature) and separate from any promotional literature.
In short, FDA calls for an emphasis on science—not promotion. As such, the guidance also calls for manufacturers to ensure that literature is not false or misleading, and does not contain information that could endanger a patient.

www.raps.org/focus-online/news/news-article-view/article/4717/fda-releases-guidance-on-use-of-scientific-and-medical-literature-for-promotion.aspx

SO this abstract has been accepted at a well renowned medical meeting in the form of an abstract and I would think you could present this to Onco docs for their review. I think it will help in the marketing and greater acceptance of Folotyn. At the very least it can’t hurt.