Under those statutes. Nothing she did is illegal. It is not even close. A prosecutor would be laughed out of court. Nothing was knowingly or unknowingly removed from it's proper place of custody. There isn't a shred of evidence that any e-mail was hacked or went anywhere other than intended. You don't even get to the intent argument, which is implied in the "knowingly" part of the statute, and of course contrary to the trumpites ignorance is properly a huge part of the Statutory framework of our countries laws. Foley you are too smart to argue with these idiots.
The results will be the results. Their should be proper oversight, whatever that might be, so that the results are true and accurate. I don't care who is doing what. Plus nobody knows which way the FDA is leaning or what significance they attach to this additional data. EVERYBODY long and short is concerned. Nobody knows which way this goes. There are only educated guesses and gambles. I'm long (formerly just calls but now the stock also) but I am prepared to lose it all. Anyone on either side of this who is not so prepared should be out. The funny part, and the only guarantee, is that whomever is right we will see 50 posts from that side saying how obvious it was that this would be the outcome. Nothing has ever been less obvious IMO.
Just stuck my toe in here for 3k SH long --my thinking is that the prez debates, which will have monster TV ratings, will expose a new (older) demographic to twitter, since the circus clown uses it to communicate his/her ...um...stuff...so often, and the other candidate does as well. (trying to stay away from politics so not saying which one is the clown(ess)). In my minds eye, I can see the tweets up on screen while the questions are being asked to the candidates right now. Not sure if this has been talked about here or anywhere else, but I'm making a bet it is going to happen and new user activity will pop big before November elections.
My guess is it is around a time where market starts thinking that about enough time has passed to get the FDA the data and the WBs, and the longer it takes from here the more the sentiment will be that the results are negative (the thinking being the more positive it is the faster SRPT gets it to the FDA). Not saying this is logical but I do think it is a retail feel at this point. So IMHO this could drop until they PR that the data was exchanged, and on that day the PPS gets a big pop back up. This is all just my personal speculation.
So I see the debate about this. What if the NVAX NP flu vaccine is equal to existing flu but not differentiated by providing broader protection/greater immunogenicity? Isn't that good enough? As long as it makes it to market as an equal then the combo with the RSV vaccine seems to me like it would be differentiation enough to capture a huge segment of the flu market. Who is going to get 2 separate vaccinations when they can get both RSV and FLU protection in one. What, if anything, am I missing here as when we talk about a combo RSV/FLU vaccine I don't see how for commercial success it is vital that the flu vaccine be identifiably superior to others.
Sentiment: Strong Buy
ok DB thank you for this revelation. I guess I will sell then. Thanks for clarifying that the conservative Pfizer only handicaps PH2s in the vaccine space, would never buy a PH3, and since they haven't bought NVAX yet, which wasn't for sale, they have determined that PH3 elderly will fail. You are very wise indeed.
Sentiment: Strong Buy
You are indeed clueless if you think that among the literally uncountable thousands of PH2 trials that any BP can look at, that Pfizer or anyone else is out of the running to buy post PH3 ANY company simply because they did not buy it post PH2. The comment matches the idiocy of saying that NVAX management is superior to Pfizers simply because NVAX bought a single compound (matrix M) that Pfizer did not. But I get it you stand with your post-that ultra conservative Pfizer calculates the approval of all takeover candidates after PH2 only, and once it fails to make a PH2 purchase (in this case of a company not for sale), that it is out of the running after a PH3 success. LMAO.
DB you cite Pfizer's "conservatism" and that they would "not throw SHs money around" and they wait for a "guarantee of success" yet at the same time say if they were to buy NVAX "they would have done it by now." Meaning they would have bought it before even a successful PH3 trial? You must realize that your post is at least as nonsensical as the one you criticize. Clearly Pfizer is a potential NVAX suitor contingent upon a successful PH3.
99% It is one and done. Despite the "from time to time" language the PR is standard language which just recites various factors that may be considered in pricing the raise. I will go out on a limb and say the price will probably come tomorrow. I will guess the raise at $19.50. Second guess is that fact that are buyers of almost 2M shares at about market causes, under circumstances, SP to jump to $22ish after announcement.
Hey dummy. They raised less than a quarter of cash burn. It is so bullish. It could take the FDA a friggin quarter before they issue an AA. If they didn't have AA confidence, they would have done a raise at last 10 to 20 times this paltry amount.
Actually magnum I don't think that is correct. You are describing an ATM (at the market) offering. I think this is a regular offering to raise 37.5M with the amount of shares (eg; offering price) not disclosed yet. However I agree with you that it is very positive. It is a VERY small amount and to me signifies that SRPT believes they will get an AA. This small offering will give them the comfort level necessary to operate until the FDA makes a decision plus any time they need to arrange for a much more significant offering after AA. If they did an offering today for 200-400M I would say that is bad. This offering I view as a very good sign for longs, at least in terms of measuring the confidence level that SRPT management has in getting AA.
Sentiment: Strong Buy
After yesterday u would expect significant pullback given IBB down $7 today, but buying still strong- clearly other marker forces at work. Next move on the IBB and ACAD is good for another $2-$4 pop IMO.
I'm usually not one for predictions but I'm guessing this $5 bounce is just the break even on the "short" pile on after the CU spec nonsense. We are owed a bounce from here both from the old shorts and pile on shorts. Would not be surprised to see $26 or higher today. Alternatively of course, I could be wrong.
Agree 100%. If the biopsy samples are favorable then it has to be an approval. No way at this juncture can they say give us this last thing and then we will promptly decide, and then have it be favorable and the FDA rejects. Not possible not possible not possible.
Sentiment: Strong Buy
I wouldn't use the word imminent but YES great news. Sure as heck looks like FDA is looking for something to hang their hat on to give AA!!!!!!! What better way to go against the ADCOM vote and save face for Farkas and the other dooshes but giving the AA at least in part based on info that was not available at the ADCOM!!!!!
He felt constrained by the wording of the question. While I agree it might sound offensive to the families, I believe his explanation of how he felt he had to vote based on the wording of the question is a helpful part of analyzing why there should be an AA. The FDA should see the question was not properly composed, and that his answer would have been YES if it were. If they don't realize that at this point then they are dumber than the dumbest of dumb. It is so public that I do think they must have talked somewhat about the inconsistency bw the ADCOM question and FDASIA. By the way I just saw the UCLA video everyone should google it (or find it on twitter $SRPT) and watch it they put together the most relevant testimony from ADCOM it is absolutely great. It has some Onyike comments and also I realized for the first time a female "NO" vote was bc she said although she thought there was dystrophin production the data did no show a "CLEAR" benefit. I am open to being corrected did she say that?? The standard is not "CLEAR BENEFIT". If I recall it is "MORE LIKELY THAN NOT" that it confers a clinical benefit. That would be possibly the 3RD vote (I'm adding Onyike and the guy who said it "definitely works" but I'm still voting "NO") that might differ had the panelists been presented with the correct standards in that ADCOM question. I think the FDA should have discussed by now that under the correct legal standard the vote might have been 8-5 in favor of AA. BTW as long as I'm rambling I differ with those that exclude the possibility of compassionate use just bc Woodcock said that the completion of the refined standards are not specific to any drug. Ease for compassionate use have been streamlined and it would be easier for DMD boys under the new guidelines than the old. Plus C.Use was always possible outcome .Don't get me wrong I still think anything but AA is untenable.Hoping the current discussion is w/ SRPT about post approval conditions. No way should this be a NO.
it only could go one way...potential volatility causes brokers to make particular stocks less marginable. At scottrade almost every biotech I have owned has more restrictive margin requirements than those imposed by the general price per share based limitations
Yes. No marketing, no sales force, no education process. Relatively speaking, a monkey could launch this. Just need that AA.
Tat- so I un-ignored you (only for as long as it takes to write this) to see what possible relationship one could draw bw CPXX and NVAX. Well as Lobster said the stuff you made up out of whole cloth re cap on NVAX PPS is comical. Also, just as and FYI, one of the most foolish things one can do is go out and look for a CPXX. What they did works 1 in 10,000 times, which is to fish through data for a subset that was not pre-defined, in a failed trial, and then run a new trial on that subset praying for the hail mary that the purportedly positive results in the subset represent something other than a standard deviation that always exists in one or some of literally thousands of subsets you can identify after the fact in any failed trial. That said I know a little about CPXX because after this little miracle happened, I was quite impressed at the data (10K shares worth and in and out and ultimately sold 8k SH bought at 17ish for $29.99. Do the math). Anyway, CPXX was far from genius, at least in retrospect, regarding financing. They did a dilutive raise at about $9 immediately after the results and of course all of this lost equity could have been sold at the $30.25 buyout price only a few weeks later.