Investors were initially impressed with Wotten & gave him a lot of credit for turning the company around. If you really look back on what he did then his success had more to do with market dynamics then his leadership. In the later stages more investors came to realize he was a irritating jerk & were happy to see him leave.
They're just going to report data on the 1mg & 2mg dosing in November which is not going to move the stock. You need positive safety date on the 4mg & good results from the 3mg dosing to move higher.
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
QST won't be the first choice for most individuals once an oral option is available. QST will be more expensive then gels so the market will be limited to a sub-group. Its the same story with Otrexup. Yes, it can succeed in the market but its not a slam dunk.
I know your going to tell me how big the market is but I heard the same thing with Otrexup & the launch can only be described as steady.
I'm not desperate, there's just a lot going on with testosterone products this week.
Clarus approval would be negative for several reasons.
1. The whole argument of cross transference goes out the window.
2. I'd rather use SQ then gels but I'd rather take an oral then SQ.
If the FDA asks for a post-marketing CV study then I imagine the same thing would happen with QST.
All of us know the efficacy of oral testosterone products are not as good as SQ but it would potentially slow the uptake of QST.
When you find the part about the FDA looking for better ways to control testosterone levels in the blood that are predictable & stable let all of us know. The only place I could find it was in one of Wotten's old presentations.
An expert panel voted overwhelmingly on Wednesday for the Food and Drug Administration to impose strict new limitations on the multibillion-dollar testosterone drug industry, recommending that the agency tighten labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy and libido. The F.D.A. often takes the advice of such panels.
Once used only to treat serious medical conditions, testosterone drugs are now taken by over two million American men, mostly for symptoms that are largely a result of aging, a pattern that has alarmed some medical experts. If the F.D.A. adopts the panel’s recommendations, it could sharply reduce the number of men prescribed the medicines and clamp down on marketing of them by drug companies. It could also limit coverage from insurance companies for their use, experts said.
Has LOKO ever given you any potential revenue numbers for those programs? The reason ATRS moved away from those deals is because they don't generate significant revenues.
I'm not a subscriber to the website so that's all the text given without a subscription. The main point is that the FDA will make a decision on the 18th which impacts the value of QST. Its easy to investigate the efficacy & data issues. I actually think they get approved.
- If It Can Overcome Efficacy Concerns FDA advisors will have to tackle missing data in pivotal study of Clarus' Rextoro when they vote on efficacy and approvability Sept. 18, one day after scrutinizing safety of all testosterone replacement products.
How do you know that Éclat II has not launched? Management stated it would be launched in the late 3rd qtr ?
Éclat III NDA will be filed in the 2nd half 2014.
Eclat IV NDA in the first half 2015.
It looks like a lot of programs are moving forward for such a small company.
On Tuesday, November 27, 2012, a U.S. federal trademark registration was filed for OTREXUP by Antares Pharma Inc., Ewing, NJ 08628. The USPTO has given the OTREXUP trademark serial number of 85788191. The current federal status of this trademark filing is NON-FINAL ACTION - MAILED.
NON-FINAL ACTION - MAILED
Estimated Response Deadline: 9/24/2014