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.
Tennis, why was your family member prescribed Otrexup? Was oral methotrexate not working or were they having adverse effects? Were they already using methotrexate injections to manage their disease? If so were they giving themselves SQ injections or going to a doctors office for their injections?
Nammuang, could you point to me where in the press release ATRS is mentioned? TEVA has launched a number of products which utilize an injector since they signed the last agreement with ATRS. Why do you think they will use ATRS for this product? Its all pie in the sky projections & that's why posters jumped on your post.
I'm not holding any EXEL but I booked a nice gain in HALO today. Sold at $10.25 in pre-market. Thank you for asking.
of a SQ version in 2017. In order to do that they will have to obtain positive results in clinical studies & as anyone that follows biotech's knows timelines are always overly optimistic. If they file for approval in 2017 it would mean on the market in 2018 or 2019 at the earliest.
TEVA won't know that until they conduct PK/PD studies & clinical trials. Just because a drug works IV doesn't mean it also works SQ or IM.
There was a net increase in institutional buyers in the second qtr & Deerfield didn't sell any shares so what are you talking about?
Looks like someone sells in the morning, a buyer steps in who takes it above $15, & then another round of selling takes place. One of these days the seller will be finished & the uptrend will continue.
Robert Hornback BAX CFO So first, I think the HyQvia launch in Europe is going very well. As we've talked about, we've been very targeted about the markets that we've launched in and have done a very controlled launch to ensure that we get this off to the right start with both patients and treaters, and so the initial feedback has been very good and patient experience has been very good, which is very important to us for the long-term positioning of this product. We are pleased with our ability to, I think, get the innovation we've brought to the market recognized in the price point that we've been able to achieve in some of the markets in Europe, and so we do have a meaningful price premium in those markets today and we expect, as we hope to get approval here by midyear 2014, that we'll be able to do the same in the U.S. In terms of our ability to supply the market, as I mentioned earlier, given our assumption around overall demand growth of about 6% to 8% on a global basis within our existing footprint, we will be able to provide volume unit growth in the 6% to 8% range, both for 2014 and 2015. As you saw though, we have selectively -- given our product constraints, we've selectively targeted which markets we want to participate in for the long run, and so while that's depressed our sales a little bit in the short term, in terms of some of the markets we've exited in Europe as an example, it does position us well to continue to participate in the strong growth in the U.S. market, and certainly, we think HyQvia would provide a significant differentiation for us in the U.S. So we're excited about that opportunity. And we'll be in good position, as our inventory levels have improved in the U.S., to support strong demand going forward for that product. And in terms of overall market dynamics, I don't want to talk about too much here in specifics. But I would say that no real change, strong demand, and again, our ability to supply at-market growth
Original filing was Dec/2nd with a 6 month review would have given June/2nd as the PDUFA date. Normal extensions are for 3 months so that gives Sept/2nd as the new PDUFA date but its not set in stone.