Dendreon Corp fka DNDNQ

[nmstav]

Post by tooskookum4u on IV board -

MB#132679


483 - relax people...

483s run the table between paperwork issues (not all workstations have policy and procedure manuals next to them) to facility issues (improper air handling equipment) to maintenance plan issues (planned airhandling filter changes every 2 months instead of every 4 months) to product issues (product is not stable).

Fixing these issues can take from 10 minutes (copy policy manuals to a workstation desktop) to years (stability issues). I have never heard of any new facility receiving a first-inspection pass. When a NDA or BLA involve the inspection of a new facility, it is very common for the final CMC issues to be resolved in the last few days before the PDUFA date. The issuance of a 483 is consistent with this and would not hold up or delay approval unless it could not be resolved ahead of the approval date AND it was serious enough for the FDA to withhold drug approval (relatively rare) until the situation is fixed.

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.

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.

CRL can be resolved with either a class 1 or a class 2 response. Class 1 responses require the FDA to respond in 60 days. Class 2 responses require the FDA to respond in 6 months. The "class" of response is assigned by the FDA after the company submits their amended applications. In the case of minor manufacturing issues, it is almost always a class 1 (60 day) response.

The Provenge CRL would have the manufacturing issues added in to the letter because the FDA did not talk with Dendreon between the panel and the decision. Note that Dendreon said their formal (Type A) meeting with the FDA specified only efficacy data was necessary for approval. NOT efficacy and MANUFACTURING changes.

Relax...

1. Dr. Urdal said the issues are minor and David would never lie.
2. Dendreon is producing Provenge for the 9902b trial out of NJ, something the FDA would never allow if it was a serious problem.
3. The FDA said the only barrier to approval was additional survival data, not anything associated with manufacturing. This means Provenge would have been approved if the FDA would have followed its advisory panel.

Keep your eye on the ball here. Do not let the lawyers and their hedge fund friends keep you from writing Congress to demand they hold hearings into why the FDA did not follow its advisory panel vote. The decision to delay Provenge until another 80,000+ men die had nothing to do with science, data, or manufacturing issues. It was 100% politics and only a political effort will bring Provenge to market faster than 2009.