This is a patent on solid tumors, not a specific tumor type. Huge implications for a broad application of their technology in numerous cancer types. In other words, if the Pie instead of a slice of it.
Probably because most have already sold. The bottom is in and there are better equities that will get sucked down with the market.
No where in the PR did it state the number of units. Certainly did not imply one unit purchased. Nice bash effort. I doubt if replacing one unit would reduce operating costs as stated by their company exec...Nice try....
"ETD is an important part of our ability to provide uncompromised security. Buying the QS-B220 gives us access to the most advanced technology while also reducing our maintenance and operation costs," stated Steve Panzarella Jr., President at Global CFS.
If that strategy pays off, I will be the first to congratulate Chris. It comes down to a battle of Ego,s and cat and mouse......while the disease progresses....Sad.
Copp. The FDA has already stated they want a Phase 3. Sure, an AA with a confirmatory would be preferred by DMD patients, investors, the company etc...In YOUR mind there is no need for a phase 3. However, The FDA does not agree at this point and they have stated their position, unless convinced otherwise. My point in my post, could be a "save face" Phase 3 design that would be more expedited than some believe. Fewer patients, shorter timeframe end point evaluations, strong safety component. I have already told you I admit to not knowing the details on how this could be constructed as an expeditiously designed trial, but I believe the FDA will get their phase 3 without dragging the parents and kids through the mud for 2 years. JMHO
I believe there is a way the FDA can save face and allow Serepta an SPA FDA Phase 3 that can get this product to market in more expedited manner. Many are saying 2 or more years out until market ready. I believe the FDA will allow Serepta to design a trial that will be focused on safety and the 6 MWT, that will be a close second to AA (not saying an NDA or AA is officially off the table yet). However, if the worst case scenario is an extremely expedited SPA phase 3, and clarity to the process is disclosed, the pps will come flying back. I do admit, I am not sure how the details and actual design would be constructed, but with the DMD pressure and 84 week data (soon to be released), I believe the FDA will attempt to look compassionate, without compromising their position.
This is simply a natural rotation/cycling of the pps post catalyst (NDA). If you look at the 6 month chart, the pps has cycled below it's current value several times, and many times, for no reason. The approval is several months away, so traders are taking their money and playing other short term and binary plays. If you average additional shares between 7 and 8.50, you will be happy with the 11 to 14 in 4 to 5 months due to the run up alone. This is a buyout candidate, so traders beware during the interim.
b) Proposal 2. The amendment to the Company's 2010 Equity Compensation Plan ("Plan") to increase the number of shares eligible for issuance under the Plan by 7,000,000 shares was approved based upon the following votes
The market always responds to dilution, no matter how insignificant or for what reason..dilution is dilution. Hence, the sell off post 8K release.
As of the Record Date, 68,797,964 shares of the Company's common stock were outstanding and entitled to vote at the 2013 annual meeting, of which 53,088,927shares were represented, in person or by proxy, and which constituted a quorum. The final results of the stockholder vote on each proposal brought before the meeting were as follows:
If you are invested in this company and still holding, you'll get what you deserve. Look around, there are much better places to invest.
This is a loaded spring. Volume doubling ADV, heading into the conference. I am not sure anything new will be divulged, however, I am anxious to get an update from a formal presentation....along with any vibes.
Jeff....could you copy/paste the second page (regarding the rest of their pipeline), if you can. I read the inhaler section but am blocked by subscription to the second half of the article. Yes, I am cheap. I would rather buy additional stock. TIA
The NDA has been accepted by the FDA and the clock start towards approval, buyout or a successful market launch. Do not watch the premarket manipulations by day traders, shorts etc....look at the above sentence. GLTA longs
JMO.....They have 3 business days to publically disclose a material (8K) event. Having it released on the other side of the holidays, when the markets and investors are focused and immerged, would make sense in producing a more pronounced PR impact.
I would like to believe this pps run is specifically attributable to an imminent SRPT catalysts, however, there a lot of biotechs flying this week.
10.11 based on anticipation of NDA acceptance next week. If accepted, an intraday run up, then pull back for the long approval process. A potential buyout will always keep investors holding a core position. If an announcement AH's today.....not good. I hope to not see any PR's until Monday a.m.