Replies to post #172873 on Biotech Values

[DewDiligence]

Xarelto—So new trial isn't just likely anymore…rather definitely for this indication.

Moreover, off-label use in this indication will be close to nil, IMO.

[DewDiligence]

FDA rescinds REMS requirement for Xarelto while also rejecting sNDA for ACS:

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202439Orig1s012ltr.pdf

[DewDiligence]

JNJ issues boilerplate response to Xarelto CRL in ACS, but it doesn’t ring true, IMO:

http://finance.yahoo.com/news/fda-issues-complete-response-letters-130000012.html

"We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events," said Paul Burton, M.D., Ph.D., Vice President, Clinical Development, Janssen Research & Development. "We are evaluating the contents of the [CRL] letters and will determine the appropriate next steps."

I think Xarelto for ACS is dead, period.