Jet Lag Indication... when hell freezes over

FDA Accepts HETLIOZ® (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder
WASHINGTON, Dec. 20, 2018 /PRNewswire/ -- Vanda Pharmaceuticals Inc.(Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder.

The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-VI), to be August 16, 2019.


The FDA fucked up once before and accidentally allowed a loophole so it can be used in sighted patients with non 24. They won't be so haphazard this time and will be watched closely. An indication based on a half assed study with a whopping 25 patients. It would be one interesting label though. Start taking Hetlioz 3-60 days before your expected flight.

 

Well, Simce M won’t negotiate with payers as said on investor call, no one will cover this overpriced medicine for a 30 day jet lag indication. Unless he has a managed care dept someone doesn’t know about our negotiating contracts now nothing will happen with this indication either.

 

On investoricall, poly will be spinning this very doubtful jet lag indication as the greatest indication of all times with huge potential for Vanda. Of course, a couple of the more naive analysts on the call will believe his line of feces.

 

Good luck on that jet lag indication after challenging the FDA yet again. Worst leadership ever. the board needs to clean house.

 

I am excited (NOT) waiting for a supposed jet lag indication this week. It would be exciting to be able to sell overpriced melatonin that takes six weeks to work for a "disorder" that cures itself within 24 hours of getting off of the plane. Vanda is manufacturing a solution in search of a problem. So wrong.

 

I would not bet against the company figuring out a way to turn a profit of this. I’ve been wrong every quarter. I did not think we’d all be here at the end of 2018. I thought the DOJ would have showed up and grabbed everything while we were told to back away from the desks. Somehow the stock is impervious to what we have visibility to. Criminals, but either brilliant or lucky.

 

on July 19, 2019, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of Jet Lag Disorder, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.

 

Hey Poly, it is August 16, where is that exciting news of a jet lag approval??

 

you were right!

 

The FDA's conclusions regarding the clinical significance of improved sleep in JLD are not the FDA's only observations made with respect to the sNDA. The CRL contains additional observations on various aspects of Vanda's sNDA. Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter.

"We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program," said Mihael H. Polymeropoulos, M.D. Vanda's President and CEO. "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."
They FDA finally got it right!! Wall Street could care less about this indication, regardless.

 

"We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program," said Mihael H. Polymeropoulos, M.D. Vanda's President and CEO. "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need.

Jet Lag an Unmet Medical Need - Are you fucking kidding me! Who the fuck wants to treat Jet lag with outrageously priced melatonin blocker and which insurance company in the world is going to cover for this crap for fake "medical issue"!!

 

Did you read the full article? It said there were discrepancies with post marketing of Hetlioz too. What else are they not telling us?

 

Post Marketing discrepancies...... Everyone saw that coming .

 

No one would have asked for it or written for it or any payors paying for it. Wall Street knew that too. They could care less, stock barely budged and ended the day higher than it started. But mihales and his brain dead CCO, Sales VP and field management would have acted like it was the second coming of Christ ( or Satan assuming that's who many of our leaders worship) and wanted 3 Jet lag Rxs every week. If wall Street cared at all, the stock would have taken a large hit.

 

My manager is sad because the FDA is being "cruel" with the "attacks" on Vanda. I wanted to vomit. I now think that Dr Polymeropolous put the office on Pennsylvania Ave in DC just for the address. He seems to be all about himself and his kids. Does he think he should move down the street to the White House next????? Will GP be vice president? He speaks gibberish he would be a good politician- a very unsuccessful one though.

 

Mihael H. Polymeropoulos, M.D. Vanda's President and CEO. "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."

memo to M Poly: the FDA did not just delay approval, they said NO. give it up.

 

It may be worth pointing out that pretty much everyone who worked on the previous two successful NDAs no longer works there. When the person leading your NDA submission isn't competent, none of this should be surprising.

 

The sales force and the DC office are similar, 1-2 years and gone, usually to escape the polymeropolous family incompetence.

 

Incompetence also extends to the person leading the sales force and the person leading the company

 

Who is leading the JetLag study?
Does anybody know why they rejected it?