As impressive as the stats on institutional ownership for the 3d quarter are, there are still some huge pools of investment funds that regularly invest in biotech that are not included in the latest accounting. Those would be T Rowe Price, American Funds(represented by Capital Research Global Investors & Capital World Investors), and Lord Abbett, among others. If there is even the slightest hint of good news in the offing, I believe these behemoths who are probably somewhat conservative could finally get off the fence and create a huge demand for shares. GLTALs.
Zorg, it won't help you and your henchman, Fraudstein's, cause to precipitate a big drop in price by feverishly thumbing away. You could make it a little more believable by not doing it all at once right after a post appears.
As for technkl99's post, nothing was mislabelled in Fig. 4. 128 patients finished the Arikace protocol and 134 patients finished the TOBI protocol. In between, some patients were not available for data collection. These things happen: a death in the family, an illness not related to treatment, ad infinitum. No villager or outliers were included, the protocol population is the protocol population. The per protocol population analysis was pre-specified as per the study design stated on the poster in Figure 2. I assumed no specific overlap in populations, but if it is not perfect, it is near 99%. It seems you and Fraudstein are the only ones making up "blcht" , but that is your specialty. Oh, and I don't know what benefit you get from calling me fud, but it doesn't matter, we both know you're FOS.
I didn't mention time of administration and I said nothing about the podhaler being disposable or not. What does it have to do with my central point? Both drugs have advantages and disadvantages. You just choose to ignore TIP's downside and it has a proven one, a greater incidence of annoying side effects in a head-to-head trial with nebulized TOBI. And who doesn't have a refrigerator?
Fraudstein complains that FEV data was "per protocol" and perhaps based on a restricted and cherry-picked poplulation. But he didn't even notice that the number of patients in the FEV primary endpoint analysis exceeds those in the so-called mITT analyses. In other words, a broader sample was in the primary endpoint
analysis. I am sure the statisticians used every data point that they possibly could. As has been pointed out, no human trials are perfect and you're going to lose some data, whether due to hangnail or heart attack. Fraudstein, though, immediately points to company fraud, naturally.
Your forte is trading? Weren't you the one who warned everyone about the fiscal cliff and saw impending disaster in the markets? Remember that one? The market has been on a tear ever since you gave that warning. Whatever happened to the randy camel's call for the 99 cent store? Does he get to claim that the decimal was just in the wrong place? Bottom line: you are a pathetic fraud, and if you believe that anyone swallows your garbage on this board, you are truly delusional. I am up handsomely on paper on this stock and I lower my basis systematically and regularly by collecting option premium.
Please don't feel the need to report your fictitious trades. Why not just pick up stakes and relocate your little puppet show elsewhere? Hanging around here with your cloud of gloom as the share price continues to rise just makes you look more foolish than you have proven you already are.
Biotech is the worst performing sector in the market today. Last time I checked, only 7 out of 47 stocks in the XBI were up.
Feuerstein states: Generally speaking, efficacy analyses conducted on ITT or mITT patient populations are more conservative, more stringent and more reliable than analyses done with per protocol patient populations. When you omit patients from a study analysis, bias can creep into results.
The primary endpoint called for analysis at day 168. If a good number of the original intent-to-treat patients are no longer in the study for one reason or another (through adverse events, failure to show up, standardized data outlier analysis etc.) how can you include them in the analysis? It makes no sense. Feuerstein wants data where no data exists. The poster explicitly states that among patients with severe adverse events that there was no relationship to the study drugs.
What this amounts to is Feuerstein accusing the company of cherry-picking the data, a pretty strong allegation.
Did you miss the paper, "Tobramycin Inhalation Powder in Cystic Fibrosis Patients: Response by Age Group" published this past August in the journal Respiratory Care?
It showed that the incidence of cough and loss of voice (dysphonia) was far more prevalent in in the dry powder TIP group than the nebulized TOBI group. Also the incidence of loss of taste was far more prevalent in the TIP group. This is probably because patients are getting a large dose of dry med in their buccal cavity twice a day, whereas more of the nebulized medication is inhaled.
You're making a big deal about the convenience of TIP, but when you factor in that Arikace would only be used once a day and probably would have a lower incidence of annoying side effects, who wins? I know I would rather take the time to clean my nebulizer than suffer coughs, loss of voice and taste.
What's really sad is that Yahoo allows the troll to live rent-free on this MB and looks the other way as he spews his falsehoods 24/7/365 using multiple IDs. The truth is that any day we will see results from the phase 2/3 trial, "Insulin-Like Growth Factor I (IGF-I) in the Prevention of Complications of Preterm Birth" that anyone can look up on clinicaltrials.gov in which INSM's "failed" drug was administered to premies. If results are positive, there will be the impetus to resume manufacturing of the bi-protein, which will allow researchers to continue exploring potential new indications.
He said he covered his short for a loss just before the drop and said I was full of #$%^& for predicting a fall to 11.80 as a target price from a H&S topping pattern. He ain't right, in so many ways.
So, given your complaint about some delay, how does that affect your assessment of the final outcome? How can it? Maybe management's being really selective to... perhaps...shall we say...stack the deck in favor of approval. We know how important patient selection is. If they haven't learned their lesson from the MD debacle (so far), then they really should be kicked out.
Are you related to the guy who claims he can smell over the internet?
If anything, I am somewhat perplexed by your intransigence.
I disagree that if you miss a rating during the trial, you are not following protocol. What is important is that you do not miss a dose of the drug during the trial. If you disagree, then so be it.
Your second point makes no sense. I see no evidence of imputed values. N = sample size is explicitly presented on the graph in Figure 4. Who said anything about imputed values? Point it out...pretty please.
Third point: you will have to take this up with the 18 docs who stand behind the data presented in Table 1. Their assessment was that there was no relationship between severe adverse events and treatment drugs. In fact, there was a higher percentage of AEs in the TOBI arm. Sure there were more that dropped out in the Arikace arm, but the docs in Table 1 are telling you it was not related to treatment. If you don't believe them, give us your reasons.
I hope this post stays up and I personally will make copy of it. Zorg (terry et al) is implying that the 18 authors who placed their imprimatur on this poster presentation, (among them the most respected names in CF research, including Konstan and Clancy in the U.S.), are attempting to mislead and engaging in some sort of deception borders on an actionable offense.
If I had a child with cf, I would be concerned about the greater overall adverse events observed in the group with podhaler delivered TIP in a head-to-head trial with nebulized TOBI. Did you know that there was a 4% greater incidence of ‘cough,’ ‘lung disorder,’ ‘dyspnea,’ ‘oropharyngeal pain,’ ‘dysphonia,’ ‘throat irritation,’ ‘dyspnea exertion,’ ‘nasal mucosa disorder,’ ‘pyrexia,’ ‘chest discomfort,’ and ‘dysgeusia’ in the TIP population? In the case of ‘cough’ and ‘dysphonia,’ the disparity was 5%. Did you know that overall, 51.0% of subjects in the TIP treatment group and 20.1% of subjects in the TOBI® group had AEs categorized as treatment-related? Did you know there were more discontinuations in the TIP arm than TOBI® arm (TIP 83 subjects [26.9%] and TOBI® 38 subjects [18.2%]). This disparity was driven by imbalances in
discontinuations attributed to adverse events (TIP 14% vs. TOBI® 8.1%). Most disturbing was the fact that there were 3 deaths that occurred on the TIP arm compared to none in the TOBI® arm.
The convenience of the podhaler could be offset by possible adverse events. You just have to see how TIP is tolerated in your specific case.
Sales may be climbing because TIP has only recently become available and works for lots of patients. But if Arikace becomes available, patients will ask themselves, "Which is worse, cleaning a nebulizer or risking a proven higher incidence of annoying side effects with twice daily TIP dosing?" TIP is not all roses and lollipops as you seem to profess. You talk about facts, but only the ones that suit your agenda.
There has been no interruption in the upward trendline that can be traced back to 2/27/13. It was challenged on 10/9/13, when a gap at $12.16 missed being filled by a mere cent. If you remember, at that time the entire biotech sector was experiencing a sell-off with the Spider Biotech Sector Fund XBI hitting its low water mark since 7/10/13. The subsequent Fraudstein hit-piece had a far less significant effect, probably because there aren't very many dreamy, gullible, uninformed holders left.
So now, we have a support line which is much more steeply upright, which forms the bottom of the pennant you have pointed out. I've always debated whether I should chart exponentially or not. But it is interesting that the latest steep support line in an arithmetic chart merges very well into a longer term exponential support line back to 2/27/13. This tells me we are about to go exponential.