Posts tagged ‘FDA’

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.

We’re Back!

After a long hiatus, we are pleased to announce that we will begin posting opinions about FDA events again.  We also would like to announce the addition of  two new contributors to our site, Dan Heathwood and Tim Shields.  Both are private investors with previous experience working as research analysts for some well known investment firms.  Their past contributions outside of pdufadate.com  have  helped translate our opinions into sound stock trading advice.   Our first post will probably deal with Durata Therapeutics (DRTX) as we continue to receive numerous emails about dalbavancin.

There will be lots of changes to our site so keep checking back.

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.

Diet Drug Special Report is Available

With the Vivus‘ QNEXA PDUFA scheduled for April 17,2012, we have created a special report that reexamines all of the obesity drugs that have been reviewed by the FDA and the Advisory Committee since 2009 to determine if any additional insight could be gained regarding the expected action the FDA will take on QNEXA. The report can be purchased by clicking here or by going to http://www.pdufadate.com/premium-reports.

We changed our automated delivery method with the NORTHERA report so when you do purchase the Diet Drug Special Report, please make sure your spam filter accepts email from pdufadate.com.

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.

VOTRIENT (pazopanib) FDA Oncology Drugs Advisory Committee Meeting

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.

TALTORIC Oncology Drugs Advisory Committee Meeting

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.

QNEXA Advisory Committee follow up… Think about this

I’ve had a few days to think about this and still have a difficult time understanding the Advisory Committee vote. I admit that I didn’t see this coming. Maybe I should have. After all, this committee (with different members) gave a thumbs up to CONTRAVE. And what happened with CONTRAVE? The FDA went back to the basics of the drug approval process, the basics of benefit risk, and determined that the sponsor had not satisfied the regulatory requirements.

Will the same thing happen with QNEXA? I don’t know what the FDA will do, but I do know what they should do. Efficacy doesn’t seem to be an issue although there doesn’t seem to be any additional weight loss after 1 year of treatment. With the unanswered, it seems likely that if approved, use beyond one year will be limited.

But let’s look at the safety issues. The two biggies are sitting right out there – cardiovascular risk and teratogenic potential in women of child bearing potential. Both of these are unknowns at this time and both can be answered. The question for the FDA is whether the answers should come before approval or after approval.

Teratogenic risk: QNEXA is a teratogen. The population at risk has a high percentage of women of child bearing potential. The component responsible for the teratogenic risk is already available for the treatment or migraines and epilepsy in a population that contains women of child bearing potential. The issue here is not the approvability of the drug but rather the adequacy of the REMS program and the labeling. Can the FDA and the sponsor work this out before the PDUFA Date?

Cardiovascular risk. The FDA has raised this issue in both of their Briefing Documents. The previous Advisory Committee had this as one of the major outstanding issues they used to support its 6-10 vote against recommending approval. The FDA is concerned enough about cardiovascular risk with obesity drugs to call for another Advisory Committee meeting with this as the sole topic for discussion next month. Now, the interesting thing is that the upcoming Advisory Committee meeting is going to be another meeting of the Endocrine Metabolic Drugs panel, the same panel that just recommended approval for QNEXA. The FDA will probably invite a lot of cardiologists, more than were at the QNEXA meeting. The cardiologist vote for QNEXA was split, one for, one against approval. The negative vote was very negative. It is unlikely the FDA will make any decision about resolving the cardiovascular risk associated with QNEXA until after the March Advisory Committee. If the Committee continues to support the current FDA reequirement that studies that rule out cardiovascular risk must be completed before approval then the decision to be made by the FDA is obvious. If however, the Committee recommends that in some circumstances these studies can be conducted post approval, the question then becomes whether the FDA and the sponsor can work this out before the PDUFA Date. They would have to agree to the protocol for such a study and agree on labeling that identifies the absence of information that defines the population at risk.

I’m of a view now that QNEXA will be approved for the treatment of obesity. The questions of when and with what kind of a label still remain. It is unlikely it will be approved at its PDUFA Date. How long after the PDUFA Date is a question that can only be answered after the March Advisory Committee meeting. A point to keep in mind – while we are focusing on the approval of QNEXA, the FDA is also thinking about the precedent it will set for other drugs in the review/development pipeline.

QNEXA Advisory Committee follow up

I have to compliment the folks at Vivus, they did a great job.  Good enough to convince the Advisory Committee to recommend approval.  The big question is whether they convinced the FDA.  We’ll find out in a couple of months.

The AdComm does require a comment though.  If I had heard the commentary from the AdComm members without knowing their vote or the overall vote, I would have thought the overall outcome would have been negative.  Almost everyone of them expressed reservations about the CV signals and a concern about the teratogenicity. They used words like “trepidation”, “inconclusive”, “difficult decision”, “reservations” and the “risk is real”.  And those were the panelists who voted YES. Most interesting were a couple that deserve noting.  Regarding benefit risk, one panelist noted that because the drug is not 100% effective and presumably because those who will respond are not predictable, there will be patients who have the risk but not the benefit.  The most unusual comment from a YES voter who had reservations about the teratogenic potential was “the baby gets no vote”.  Dr. Lauer seemed to reflect my opinion best.  He viewed the results as surrogate outcomes…based on hopes not data and reminded everyone of previous similar enthusiasm for antiarrythmics that looked good but killed people.

It will be interesting to see which words resonate with FDA, the YES votes or the reservations.

NORTHERA (droxidopa) Advisory Committee Meeting

On Thursday, Feb 23, 2012, the FDA Cardiovascular and Renal Drugs Advisory Committee will meet to discuss Chelsea Therapeutics NORTHERA (droxidopa) NDA for use in the treatment of some very specific aspects of orthostatic hypotension.  Chelsea asked for and was granted Orphan Drug designation.

The drug seems to have a positive short term effect but there are a lot of serious concerns about safety, both from data that have been reported in the clinical trials and from post marketing reports from Japan where it is approved although at a lower dose.  At least equally important to making a decision are the unanswered questions about efficacy and safety.  The FDA has listed the known problems as well as the deficiencies in the data base in their briefing document and conclude that the drug is not ready for approval.
The Advisory Committee will likely agree with the FDA conclusion on this drug.