Correction to this Post.
The comments from our previous post earlier today may have been misunderstood. The post may be incorrectly giving investors the impression that Navidea Biopharmaceuticals, Inc. has not been given an “official” PDUFA date. They have indeed been given a firm PDUFA date. That date per the FDA’s official correspondence to the Company is June 10, 2012. This is the date they have disclosed in their press releases and SEC filings and it is official. However, as previously noted, June 10th is a Sunday. It is understood that is that this date is calculated based on 10 months from the date the NDA was accepted, August 10, 2011. As far as the actual “date”, it is unclear in this case since the PDUFA date falls on a Sunday whether or not the FDA would communicate the NDA status to Navidea before the weekend or on the next business day.
Original Post: Brent Larson, CFO of Navidea Biopharmaceuticals, Inc. (NAVB), told me today that they have not yet received a firm date from the FDA for the company’s PDUFA Date regarding Lymphoseek (Tilmanocept). There has been confusion because the FDA issued a June 10, 2012 date in a letter to the company. This date has been used in company press releases and its Form 10-k.
June 10, 2012 is a Sunday.
The company is hoping the actual PDUFA Date is close to the original date provided by the FDA. Past experience has shown the probable PDUFA Date will be the Friday before the intended date.
On Tuesday, March 20, 2012 the FDA Oncology Drugs Advisory Committee will discuss the supplemental application for GSK‘s VOTRIENT (pazopanib) to use in the treatment of patients with advanced soft tissue sarcoma.
On it’s own, this drug would probably not get a favorable recommendation from the Advisory Committee because the FDA Briefing Document challenges the clinically meaningfulness of the results on PFS and OS. However, when compared to the results they will have also reviewed for the Merck product for the afternoon session, these results will seem quite impressive in the same indication, ie, a three fold improvement in PFS and a 20% improvement in OS. We think this will get a positive endorsement from the Advisory Committee.
On Tuesday, March 20, 2012, the FDA Oncology Drug Advisory Committee will discuss the Merck and Ariad‘s application for TALTORIC (ridaforolimus) in the treatment of metastatic soft tissue sarcoma and bone sarcoma.
This has to be one of the shortest Briefing Documents ever prepared by the FDA for an Advisory Committee Meeting, and rightly so. There are just not that many good things to say about this drug.
The company tried to convince the FDA that PFS was an adequate surrogate for OS. The FDA wasn’t convinced but they agreed in a Special Protocol Assessment to an improvement over placebo control of 25% The company failed to meet this hurdle with only a very small numerical improvement that failed the agreed statistical mark, is of questionable clinical significance and failed to achieve the expected target even for placebo of 6 months of PFS. Match this non-significant improvement against the adverse experience profile and it’s impossible to see how this drug can be viewed as having a positive benefit risk.