Replies to post #4219 on Dendreon Corp fka DNDNQ

[iwfal]

Resolution of certain minor 483s can be made conditions of approval of a drug, meaning resolution is NOT required before approval. I would guess more than half of new drug approvals for drugs produced out of a new facility have some outstanding manufacturing issues at the time of marketing approval.

This is, of course, what I was saying earlier. It would surprise me if most new manufacturing facilities didn't have some issues at first inspection. And that many do not hold up approval.

Dendreon is producing drug for 9902b out of the NJ manufacturing facility. This was stated at the ASM. This means any 483 items are minor and would unlikely have caused any FDA approval delay -- especially a significant delay.

This is the key piece. The likely nail in the coffin of this silliness.

[DewDiligence]

>Dr. Urdal said the issues are minor and David would never lie.<

This statement came from a serious poster?

>Dendreon is producing Provenge for the 9902b trial out of NJ, something the FDA would never allow if it was a serious problem.<

According to whom?

>The FDA said the only barrier to approval was additional survival data, not anything associated with manufacturing.<

Wrong, as can immediately be verified by perusing the May 9 CC transcript.