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.