Archive for the ‘PDUFA Dates’ Category.

Durata Therapeutics – dalbavancin

Hello All!  I’m Dan Heathwood and this is my first post with PDUFADATE.com.  I am excited about this venture for a couple reasons.  First, I get to address a pretty big audience.  This site still gets thousands of unique visitors every month even though there hasn’t been a post in nearly two years.  Second, I get to pick Dr. Kennedy’s brain on events that I am interested in before anyone else does, including hedge funds, private equity groups and private investors.  To me that is an incredible edge!

Now for the good stuff.  Durata Therapetics’ dalbavancin.  There’s not too much to this opinion.  I will quote Dr. Kennedy after he read the FDA briefing document, “This is a no brainer”.  I will take it a step further. The approval of this drug is a virtual guarantee.  It’s already been recommended 12-0 by the AdComm in March. Let me repeat 12-0. And there has been so much written about this drug and it’s effectiveness that I don’t know how to condense it into a short post.  It’s simple, if it’s an effective drug it will be approved and dalbavancin is effective.

I will stop riding Kennedy’s coattails and bring some value to this post as well.  So we all know dalbavancin will be approved. Now what?  How am I going to trade this?  After a run-up to  $16.65 in March in anticipation of a positive AdComm outcome, the stock pulled back a little and dipped below $12 for short stint in April.  I wish I could say this is when I jumped on the band wagon but I did start buying a little bit later so I am still pretty pleased with myself.  However, I was advising my friends that they should buy up to $15.00    At $15 I was confident I would be getting at least 10-15% return on my investment. You need to make sure you make a decent profit for the risk you taking and at $15 I didn’t think it was a risk at all.

As I write this DRTX is trading over $17.  To be blunt, at $17 this stock is oversold.  If you’re not in it now I think you missed this one.

UCERIS PDUFA Date Delay

This past week, the FDA told Santarus, Inc. that it was extending the review period for their ulcerative colitis drug UCERIS by 3 months.  The FDA extended the PDUFA Date to January 16, 2013 because they need more time to complete the review.

I usually don’t comment on share price or share price moves but I’m making an exception here.  The stock dipped on this news.  I can’t figure these things out.  It might not be negative news.  I don’t think the FDA has a mind set that says “This application won’t be approved but we need more time to review the bad data”.  I think the contrary holds.  If the FDA sees some merit in an application, it will take the extra time to support the approval.  There is still a PDUFA report card and extending the review period for a drug that will eventually be rejected doesn’t make sense.

The Last Days of the Diet Drug Dilemma

Those of you who read our Special Report on Diet Drugs got a heads up on both the extension of the QNEXA PDUFA Date and the easy time that LORQESS had with the FDA Advisory Committee last week.  But now it’s crunch time and the folks at Vivus and Arena Pharmaceuticals are supplementing their diets with fingernail sandwiches.  Arena has the shorter wait at this time, June 27, 2012 is still their PDUFA Date for LORQESS.  By virtue of the extension, Vivus has to wait until July 26, 2012.

Neither the FDA nor the Advisory Committees have questioned the efficacy of either drug.  Neither set of reviewers have tried to say one is more efficacious than the other.  I agree and would call them equally efficacious.

Both drugs have reported or perceived cardiovascular side effects.  According to the Advisory Committee earlier this year, such drugs should be required to have cardiovascular studies performed before approval.  However, both drugs were submitted for approval and under review when the recommendation, and it is only a recommendation, by the Advisory Committee was made.  That being said, the FDA has a certain degree of leeway in forcing this requirement as an approval requirement.  In my opinion, the FDA will give both companies a break and allow the required study to be done as a condition of approval.  It will be the most closely watched event since the OJ trial.  One might think that QNEXA has the leg up on this because they went to the Advisory Committee first, but in this case, one would be wrong.  Both companies got the information at the same time – from listening to the Advisory Committee live and in person.  Who has the edge on having the protocol in final form?  I don’t know and neither does anyone else except maybe the FDA and I heard they ain’t talking.

FDA doesn’t have to talk about the cardiovascular protocol race because the race isn’t about the cardiovascular side effects, its about the teratogenicity risk.  FDA is breathing a sigh of relief with the data from Arena and the positive vote from the Advisory Committee for LORQESS.  The pressure is off – they have a viable diet drug alternative to QNEXA to satisfy those screaming for a new drug.  And they have an alternative that is not a teratogen.  Even if LORQESS gets an extension of the PDUFA Date from FDA to tidy up their cardiovascular study protocol, they will still be ahead of Vivus who has a somewhat longer struggle with the teratogencity issue.

Navidea Biopharmaceuticals, Inc. – Lymphoseek PDUFA Date

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.

BENLYSTA – PDUFA Date

Last month, the FDA Advisory Committee recommended approval for the HGSI/GSK drug BENLYSTA for the treatment of lupus, the first new treatment for lupus to come down the road in decades. We pointed out the difficulties the FDA would have with conveying the safety and efficacy information into a meaningful package insert.  The Committee either looked beyond that or thought the regulatory obstacles facing the FDA as they try to write the package insert could be easily overcome.  While we provided some wording suggestions at the time, we don’t think the FDA can resolve this issue in a timely manner, certainly not before the PDUFA Date of December 9, 2010 unless HGS and GSK both want this approval so badly that they roll over with a very restrictive package insert.

XYREM – PDUFA Date

October 11, 2010 is the PDUFA Date for Jazz Pharmaceuticals’ (JAZZ) XYREM for the fibromyalgia indication.  The drug is currently approved for narcolepsy.  Jazz  presented the XYREM fibromyalgia data to the FDA Advisory Committee on August 20, 2010 and did not receive a positive recommendation from the Committee.  The Committee rejected their REMS proposal 20-2.  It is unlikely the deficiencies in the REMS will be overcome by October 11, 2010.

PDUFA Date – STACCATO loxapine

October 11, 2010 is the PDUFA Date for Alexza Pharmaceuticals STACCATO loxapine, an inhalation formulation of loxapine intended for rapid treatment of schizophrenia and bipolar disorders.  The company reports that this is the first NDA that it has submitted using the STACCATO inhalation technology.  Phase III clinical studies are reported as having been submitted that support both indications but few details are available other than reports that both primary and secondary endpoints were met.  Getting approval for both indications using new technology seems like a bit of a hurdle for a company that is submitting its first NDA.

DYLOJECT – PDUFA Date

October 3, 2010 is the scheduled PDUFA Date for Javelin Pharmaceuticals DYLOJECT for the management of post operative pain.  The company has been silent on any actions that may have been taking place with the FDA on this submission.  One possible source of a delay on the approval of this application could be gaining assurance that the problems that led to the withdrawal of the product in the UK earlier this year are not potential problems in the US.

ZALBIN – PDUFA Date

October 4, 2010 is the PDUFA Date for the Human Genome Sciences product ZALBIN for hepititis C.  We’ve not seen anything since the company announced that it had received a Discipline Review letter from the FDA on June 6, 2010.  The FDA cited Benefit/Risk issues for the dosing regimen.  The company indicated at that time that they thought licensure was unlikely.

GILENIA – PDUFA Date

The PDUFA Date for GILENIA (fingolimod) is September 21, 2010.  This Novartis drug for the treatment of multiple sclerosis was reviewed by the FDA’s Advisory Committee in June of this year and received an overwhelmingly positive endorsement.  There is little reason to believe that the FDA won’t be concurring with the Committee’s recommendation and approving this drug.