10/10 total 411 new 220
10/03 total 548 new 325
09/26 total 523 new 319
09/19 total 464 new 259
09/12 total 435 new 233
09/05 total 430 new 241
08/29 total 472 new 298
08/22 total 464 new 275
08/15 total 416 new 272
08/08 total 369 new 225
Good Seeking Alpha article on INCY was posted yesterday. . "Top Idea For 2H14 With 2 Free Call Options Driving M&A Valuation To $93, Gilead Most Likely Suitor"
You have to be kidding, how low can you go?
"The agency notes that its analysis over the past five years shows a significant increase in the use of testosterone treatments. In 2013, 2.3 million patients received a prescription, up from 1.3 million in 2010. And men who are between 40 and 64 years old accounted for approximately 70% of all men prescribed such a drug.
More interesting data: the FDA analysis also showed this same age group had the largest relative increase in prescriptions, from approximately 850,000 patients in 2010 to 1.5 million in 2013. Only about half of men taking testosterone therapy had been diagnosed with low testosterone, and 25% didn’t have evidence of having testosterone concentrations tested prior to initiating therapy.
In fact, the FDA found 21% of patients prescribed one of these treatments didn’t have evidence of lab testing for testosterone concentrations during treatment, including testing prior to a first prescription. The FDA called this “particularly concerning,” because a diagnosis requires documented evidence of low or absent testosterone concentrations. Without this, proper dosing can’t be determined.
In short, the FDA says “there are no reliable data on the benefit in such a population.” And so, the agency “has decided to reassess the appropriate patient population for testosterone replacement therapy and to ensure that the labeling for FDA-approved testosterone therapies appropriately reflects the population for whom therapy is indicated.”
This guy's trying to recover his losses. He wrote an article Antares: May/16th "Reiteration Of My Buy Recommendation" when the stock was selling around $4 & said it was one of his biggest holding.
"Your headline says it all about the agenda you have"
I copy & pasted the yahoo headline. I guess the author of the article must be short ATRS.
The company has mislead investors for awhile. They talked about cash flow positive in 2014 & your not getting a straight answer on the insulin program.
the Baxter approval? I imagine investors are waiting for the Form 4's before they step back in.
Wait until next week. I wouldn't be surprised for them to at least reveal QSM.
I was hoping someone else would mention the FDA panel notes since I knew I'd get blasted. If the FDA decides to require post-marketing studies for any new approvals then its an issue investors should be aware of.
Andre, if your looking for a trade ENTA's PDUFA date is Dec/21st. I've been in & out of the stock but decided to reenter. Avg price $40.50.
I got about 10 tweets on this topic (FDA panel) yesterday & no one even mentioned it on the board. The big thing is that 20% of all scripts are written for people without labs showing low testosterone levels. I imagine payors will start requiring labs before approving coverage.
#1. No one on this board will post anything that might be viewed negatively.
#2. Why am I not surprised that you didn't take the opportunity to post a rebuttal but instead elected to bash someone providing important information.
WASHINGTON (AP) — The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks.
Consumer advocacy group Public Citizen said the FDA's review downplays the evidence of heart risks shown across multiple studies. In February the group petitioned the FDA to add a boxed warning — the most serious type — to all testosterone drugs about potential heart risks. Although the FDA rejected that proposal, the group's Dr. Sidney Wolfe says he still expects the recent studies about heart risks to be added to testosterone's label.
"There will be a warning and once it happens the prescribing will drop way down, and that will be to the betterment of the public health in this country," said Wolfe, of Public Citizen's health group.
Wolfe noted that prescriptions for Androgel, the best-selling testosterone drug from Abbott Laboratories, have already fallen 23 percent since July 2013.
FDA panel will meet on the 17th. According to the review documents, FDA will ask its experts whether drugmakers should be required to conduct long-term follow-up studies to assess heart risks with testosterone drugs.
The panel decisions could have a big impact on QST.