Will the FDA accept the trial comparing Lymphoseek to VBD, since colloids are not currently approved? If not, Neoprobe is waiting until 2013, when the H&N trial is complete, before they can file for approval as this trial does the comparative to current SOC, to the best of my understanding. Even with the FDA stating the H&N trial is not needed for approval during pre NDA meetings, the FDA has been known to change its mind costing millions to drug companies and investors and the citizens petition may be enough to compel the FDA to consider his argument. The argument that patients may suffer, if Lymphoseek is deemed the SOC, is worth considering as there is no controlled study showing that Lymphoseek is better than current SOC. Although we all believe and feel confident Lymphoseek is better than VBD+colloids, knowing how Lymphoseek is designed to work, has this been proven and will doctors take the risk of not correctly staging patients using an agent that has not been shown to be superior or even necessarily comparable to current SOC, even with the other known advantages of Lymphoseek?
That all being said, it's a very manipulative tactic being used by MS for his own personal gain.
At one time, the FDA didn't agree with that. They have changed their opinion during the pre NDA meetings, but what is the risk they change their opinion back?
"While the concept of sentinel node staging of cancer patients with radiolabeled colloids and vital blue dye products has become widely adopted for breast cancer and melanoma patients, no such products have been approved as sentinel node targeting agents. Both FDA and the centralized European regulatory body (the EMEA) have advised Neoprobe that in order to receive a sentinel node product indication for Lymphoseek the drug would need to be validated in a tumor type where a Lymphoseek directed sentinel node biopsy and a regional nodal dissection could be performed in the same patient. Under the scientific advice process, Neoprobe reviewed a Phase 3 clinical study design with the EMEA. The Phase 3 trial would be conducted in patients with head and neck squamous cell carcinoma"