Se il nome assurdo di questa compagnia non vi dice nulla, sappiate che sono quelli di Lymphoseek, una volta conosciuti come Neoprobe ($NEOP) o qualcosa di molto simile.

Data spostata di 3 mesi e crollo verticale... la tentazione di entrare c’è…

As part of its ongoing support of the Lymphoseek NDA review, on March 30, 2012, the Company provided as requested by the Agency, updated chemistry, manufacturing and control information related to one of several drug analytical assays. As this information was submitted within the 90-day period prior to the PDUFA date, on April 2nd, FDA at its option elected to extend the review period by 90 days to complete a first-cycle evaluation. Neither this FDA decision nor the NDA review-to-date has raised questions on Lymphoseek’s safety or efficacy.

 

Il grassetto l’ho messo io.