alive and kicking
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Did said fodder first get raised at Camp Grenada?
Dodah,
Agreed. I would really doubt that it is GTCB.
I like the sound of that!
Hmm,
I like the fact that this makes 3 days with a close over $1. Seven more and there is a good chance the delisting notice is rescinded.
I liked the smiling PIG better.
Flo,
Great picture!!!. I am still laughing. To be host with GTCB hitting $1, my expression is a lot like that pig!!!!!!!!!!!!!!!!!
The stress of living with an indecisive husband could have accelerated the visible signs of aging! :)
jesse,
I like the way you think. I was also considering that in the paper, they infused ATIII to much higher levels than normal. I am not an expert in the coagulation casacade so allow me to speculate freely. What if forcing ATIII to such high levels could trigger unintended consequences? For example, will the body react by upregulating some or all of the proteins which trigger the clotting cascade? If any of these are downstream of ATIII action, then it would bypass the effect of having the hyper levels of ATIII.
Mouton,
I should have read your post before making my last post as I was wrong about some comments. You are right that LEO will be infusing for only 5 days as opposed to 4 days in the study, which surprises me that they wouldn't be monitoring and redosing later in an effort to maintain ATIII at more physiological levels. Second, there is no mention of prescreening for ATIII levels prior to administration. However, the paper in question tried to use extremely high doses of ATIII so it is unlikely that LEO will do the same. Still, I think these are points which should be clarified by someone calling IR of GTCB.
Nice work,
Vinnys
One of the points I was making was that they were trying to drive ATIIII to very high levels for 4 days then analzying the effects on clotting a very short time afterwards. That is quite different from what GTCB/LEO are trying, to bring ATIII to normal levels in patients where ATIII had dropped to very low levels, maintaining ATIII at this more physiological levels during the entire interval of care. GTCB/Leo will then monitor survival (and presumably DIC) at multiple intervals, which I believe begins at the 28 day survival.
I just scanned the article. This section from the discussion explains some of the limitations inherent in this study, including a short duration of ATIII treatment and analysis of treatment effects, unscreened population with regard to ATIII levels etc. All in all, it isn't really anything relevant to rATIII usages in the sepsis trials.
<<the treatment with AT for four days did not reduce the overall 28-day mortality rates compared with placebo in a large phase III study [11]. Besides other factors [12], an insufficient dosage and duration of AT therapy could have been responsible for the negative results. In a recent study, prolonged duration of AT therapy guided by the actual activity, instead of a predefined dose, resulted in an effective modulation of coagulatory activation [13]. The effects of AT were thereby not evident until one week of therapy. Additionally, the selection of septic patients who may profit from AT therapy seems to be important. Patients with AT activity below 70% or patients undergoing continuous renal replacement therapies may profit most [20]. Our data seem to confirm these findings, as we did not find alterations of coagulation parameters during the four day treatment with high doses of AT in a population of septic patients not selected by AT activity or a need for renal replacement therapy.>>
<<Stocks that hit new lows, usually go on to hit more new lows. >>
Another pearl of wisdom that is obviously wrong. That would mean that once a stock started down or up, it would keep moving in that direction.
Thanks for the meaningless comment saying in the long term were all dead. That statement seems to have the same relevance to GTCB's prospects as your other statements. I like to buy stocks when they are being driven down, as long as I feel the decline is unwarranted or an over-reaction.
I didn't want to take the chance that GTCB might not drop to $0.74 again so just added 7% more shares at $0.79.
Vinny
P.S. I still have my other limit order open at $0.74.
keitern,
Yes, you need to your emotions in check. Good luck to us both.
Vinny
Right, GTCB is dropping. If you think GTCB is worthless and has no potential in the near term or long term then by all means short or sell. I happen to think GTCB has great potential, in both the near future and long term so put in to buy more today. I love it when people are short sighted and trade based on fear. Yes we will see.
How do they make rThrtombin? Is it through cell culture?
That is just too bad for you. Soon you will see only regret as GTCB rises rapidly.
There is lots of hope. We are just waiting for some of the amazing positives to finally materialize.
What about using rATIII in lung damage? Is that what they mean by burns?
I would be pretty angry if GTCB was bought at $2 a share and would bet most long investors would feel the same way. If you want only a double, then buy APPL or walmart.
For a friendly takeover, you would need to convince the board, senior management and the shareholders that an offer is in their best interests. A $2 offer now is not something I would consider. I bet that most of the above would agree.
<<For me this is the biggest mystery for 2008 >>
The year is still young!
I stand corrected. Thanks
If you use a rate of 33% for DVT in HD patients, then one assumes in a 36 patient trials, 12 patient would have had a symptomatic DVT without any ATIII treatment. Now lets play with some statistics without any knowledge. If plasma derived ATIII was 75% effective, then 4 patients (12 x 0.75) would be expected to have developed symptomatic DVT. If it were 80% effective, then 2 patients ( 0.8 x 12). If it were it 90% effective, then 1 patient (12 x 0.9). That is why I said we need to know the historical data for plasma derived ATIII. If ATIII was only 75% effective, then we are just about home free.
I already posted some data about DVT from a recent published paper. It occurs in about 40% in pregnant HD women and roughly 30% of HD patients following surgery. My assessment that one needs to see the historical controls about patients treated with plasma derived ATIII is correct. It can't be less than zero so we already know that rATIII is half way home from the European trial data uisnfg rATIII.
GTCB is trying to show non-inferiority of rATIII to plasma derived ATIII. What we need to know is what percentage of HD patients given plasma derived ATIII had a symptomatic DVT. From the European trial of rATIII, we already know that zero patients out of 14 HD patients had a symptomatic DVT.
Vinny
P.S. Jesse, you are right on the money with the stupidity of having to conduct European and US trials of the same drug. What a waste!
<<BTW, a baseball player at the plate with a 2-0 count will strike out, foul out, fly out or ground out more often than not.>>
Even if what you say is true, you are missing the point. A batter with a 2-0 count is likely to do a lot better than a batter just stepping into the box, or with an 0-2 count.
I was just looking around to see how frequently DVT occurs in HD patients following surgery, pregnancy or injury. It is pretty common as you can see below. This makes me feel much more confident about FDA approval since we have already 14 patients from the European study that didn't show symptomatic DVT. I do recall that ultrasound scans did find some evidence of some DVT in 2 patients, but this cleared up following continued treatment. Given the the FDA will be scoring sympomatic DVT, we already are half-way to approval. I know you have brought this up several times already Dew, but I enjoyed repeating it now
.
Arteriosclerosis, Thrombosis, and Vascular Biology. 1996;16:742-748.
Thrombotic Risk in Hereditary Antithrombin III, Protein C, or Protein S Deficiency
A Cooperative, Retrospective Study
Thrombotic Risk During and After Pregnancy
Twenty-five females with AT-III, 23 with PC, and 23 with PS deficiency had been pregnant at least once. The average number of pregnancies was significantly different among the three deficiency states: 2.2 for AT-III–deficient females; 2.8 for PC-deficient females; and 3.6 for PS-deficient females. In Table 5 data on thrombotic events during and after pregnancy are shown. Twenty-nine pregnancies were excluded because either heparin was administered prophylactically or the patients were not able to give exact information on the clinical history. Development of DVT and/or PE during pregnancy was frequent in AT-III–deficient females (40% of pregnancies).
Thrombotic Risk After Injury
Information on 122 injuries was available, and in 21 of these events the patients either received or did not know if they had received thromboprophylaxis; these events were therefore excluded from further evaluation. The injuries were categorized as those of the leg with cast fixation (55 events), the arm with cast fixation (26 events), and other (20 events; mostly soft-tissue trauma to the leg). After 17 of 101 injuries (17%) thromboembolism occurred. The age of patients when injury was followed by thrombosis was significantly higher (mean, 28.5 years) than that of those in whom injury was not followed by thrombosis (mean, 18.5 years; P=.0017). The youngest age at which posttraumatic thrombosis occurred in AT-III and PS deficiencies was 14 years and in PC deficiency 19 years. None of the 26 patients with cast fixation of the arm developed thrombosis. There was a relatively sharp distinction regarding age and thrombotic risk during/after cast fixation of the leg (Table 4). Whereas none of the 21 injuries in patients younger than 14 years was complicated by venous thrombosis, venous thromboembolism occurred after one third of injuries in patients older than 14 years (and in 5 events before the age of 20 years). In 5 patients thromboembolism occurred after soft-tissue trauma to the leg without cast fixation.
Table 4. Risk of Postoperative/Posttraumatic Thrombosis Without Prophylaxis
Age <14 y Age >14 y
After appendectomy
AT-III 0/8 2/9
PC 0/11 1/3
PS 0/6 2/6
Total 0/25 5/18
During/after cast fixation (leg)
AT-III 0/4 6/14
PC 0/8 5/10
PS 0/9 2/10
Total 0/21 13/34
Pretty trivial difference
jessellivermore,
I agree that this paper is very significant. It provides a molecular mechanism for why ATIII could improve survial in sepsis patients. It also explains why heparin might block the effects of ATIII. Heparin could compete with heparin like cell surface receptors for ATIII binding, and thus, inhibit ATIII binding to monocytes. This makes me more confident in the DIC trials of rATIII.
Nice find Dew,
Vinny
You are making the erronious assumption that the only difference between transgenic production by GTCB and cell cultures is the amount of protein produced.
Flo,
That recently happened twice in liver cancer trials of Nexavar, the anti-cancer drug form ONXX. As an ONXX shaerholder, that made me very happy. I would be made even more happy if the rATIII had the same good news. However, I think that would only happen in phase III trials of rATIII for DIC in sepsis.
Vinny
I think there are two issues causing the low price. Tax loss selling as many have brought up. The second is that many investors have been waiting for an announcement of the US partner for rATIII. Instead of a partnership announcement that will bring in much needed cash, we read about a deal to buy the rights to 2 more products, which requires the payment of $1 million.
I like it because it made me laugh.
The new partnerships are nice. However, everyone is waiting on the deal for the US partnership for rATIII. We need to see a deal that provides some immediate cash for GTCB in addition to the longer term and much larger milestone payments for DIC. Of course I would like to see some great rATIII data too but maybe the deal won't happen until the HD data is made public.
<<I'd ratter wait 2 more years, patients IMHO will be rewarded!>>
Well, patients who get rATIII will receive medical rewards. Investors who exhibit patience by holding onto their shares will receive financial rewards. :)
Vinny
Dew,
What is the story deal for the long awaited partnership? Did GTCB raise any hints as to when this would happen? It is now December.
Vinny
That is better than spending too much time with the goats, or is it?
<<2) Competitive risk from Transgenic Plants. while these are still far behind GTCB, the concept is a lot easier to digest (no pun intended) and could result in much better controls and social acceptance.>>
I disagree. The fear mongers will say that you can't control the spread of pollen into the surrouding environment as easily as you can stop the spread of a few goats.
<<Even at the price premium to plasma-derived AT, the sales for HD will be relatively small and Leo gets most of the profit.>>
You need to add "in Europe". We need to see what kind of a deal GTCB can make for profits in the US market.