GNTA Play of the Year
No one knows what the reason for non-approval was, as this information has not been released by the FDA. It could have been something as simple as clerical errors in paperwork, or something as crazy as facilities and their ability to produce the drug consistently and precisely.
Whatever the reason was, Genta leadership is going to sit down with FDA leadership to discuss the issues of the new drug application.
You can see from the approval of Ganite and the Orphan designation of Tesetaxel as recently as this week, that Genasense has a great chance of also gaining approval. After all, they all work in similar fashion to treat disease (Antisense Technology).
I think the FDA may want some more data, but this drug is HARDLY going to be thrown away and the project scrapped. Genasense exceeded endpoints by large margins and proved to be just as safe as chemotherapy alone.
Genasense will be approved. Get on board.
