from YMB..posting here because it provides some salient points about Advexin regulatory path for h/n from INGN's recent 10K and the bull case regarding it..
Zeta
by: verity1st 03/20/05 02:23 pm
Msg: 38494 of 38598
<<...cowboy boots too?>> …with spurs!
<<my sense of Nance is that he's kind, goes by the rules but you don't cross him..much of pride in what he does..and his heart is in the right place re: making a difference for cancer patients..as a businessman, he could have invested in a startup that would have been profitable a longgggg time ago..>>
I agree wholeheartedly. This is in part why I adamantly reject the view that Introgen’s has requested accelerated approval for Advexin because the P III trials have failed. Implicit in that view is that the company is intentionally misleading patients, shareholders and the FDA; in my opinion, that position is contrary to the actual information available to us today. Sobol has reinforced the fact that the company is still recruiting for these trials, Talbot has represented the same and added that the company is working closing with the FDA regarding, among other things, the use of P III data as a part of a confirmatory trial.
But, no one should make decisions based on what I or anyone else says. Here, however, is a pertinent portion of the 10K that addresses the use of the P II and P III data in obtaining regulatory approval.
“We have conducted a series of meetings with the FDA...As a result..., we are...pursuing an initial rolling BLA filing strategy based primarily on data from our Phase 2 clinical trials...for treatment of recurrent squamous cell cancer of the head and neck. The FDA has concurred that preliminary evaluation of this data suggests a level of efficacy consistent with the standard for the initiation of a rolling BLA....The FDA has also concluded that ADVEXIN therapy continued to show promise with respect to an unmet medical need....The FDA has also concluded that the clinical development program for ADVEXIN... continued to meet the criteria for Fast Track designation. Accordingly, we have submitted…a rolling BLA for ADVEXIN therapy for the treatment of recurrent head and neck cancer, based primarily on data from our Phase 2 clinical trials. We have further proposed to the FDA that, since the basis of the proposed rolling BLA is Phase 2 clinical data utilizing surrogate endpoints, the rolling BLA be evaluated under the provisions of Subpart H for Accelerated Approval. In order to fully explore all of the review and approval possibilities for ADVEXIN therapy, the FDA has requested we submit existing new data and analyses from the Phase 2 ADVEXIN therapy clinical trials for recurrent head and neck cancer. Given that we have two ongoing Phase 3 clinical trials in head and neck cancer as discussed further below, we and the FDA are evaluating the most effective use of the data from these Phase 2 and 3 clinical trials in the review and approval of ADVEXIN therapy. Regulatory approval approaches may allow Accelerated Approval on the basis of Phase 2 data with subsequent confirmatory data being provided by the Phase 3 clinical studies or, alternatively, a Full Approval based on data from Phase 2 and certain Phase 3 clinical trials.”
So in IMHO the public oral and written representations concerning the P III trials do not indicate failure, but instead the most efficient and effective use of this data to obtain approval of Advexin.
Specifically, the 10K states: “we and the FDA are evaluating the most effective use of the data from these Phase 2 and 3 clinical trials in the review and approval of ADVEXIN therapy. Regulatory approval approaches may allow Accelerated Approval on the basis of Phase 2 data with subsequent confirmatory data being provided by the Phase 3 clinical studies or, alternatively, a Full Approval based on data from Phase 2 and certain Phase 3 clinical trials.”
I guess either you trust management or you do not, but nothing in the public record thus far indicates failed Phase III trials. |
