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GTCB - GTC Biotherapeutics - Deel 11

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[verwijderd] 1 januari 2008 14:33

31-12-2007

GTCB 0.87 0.00 0.00%

----------------------------------------

zo ik heb er even een streep onder gezet Nieuwjaar nieuw begin 02-01-2008

?

vriendelijke groet,

[verwijderd] 2 januari 2008 10:26

Results from the U.S. study are expected in December or early January. The FDA previously granted the program "fast-track" status, which allows for a faster review process.

[verwijderd] 2 januari 2008 11:07

2008 Prediction 31-Dec-07 02:17 pm
The stock price probably hit its low today with completion of tax loss selling. Positive news starting in the next few weeks should start to help lift the price. The news events below should lift the stock to the $3 to $4 level by the end of 2008. If company provided research and clinical trials timeline are accurate it should be an even better year in 2009.

Upcoming news events:
1) US ATryn Phase 3 trial completion.
2) Annoucement of US ATryn partner in the U.S.
3) Announcement of partner in Japan
4) ATryn BLA for review
5) Announcement for ATryn partner for HD treatment (if not included in #2)
6) LEO European Phase II completion for ATryn for HD

Other potential stock movers:
1) Annoucement of CD 137 partnership
2) News from Merrimack Pharmaceuticals regarding its Phase II trial with drug produced by GTBC
3) Other new partnerships announced
4) New coverage of GTBC by brokerage houses as ATryn progresses through the approval process.

Sentiment : Buy

bron: tinylink.com/?OcnAtNG4PE

[verwijderd] 2 januari 2008 12:17

hij kan zo binnen 1 dag boven de dollar door de manipulatoren..
kan ook zijn dat ze hem 30 dagen onder de 1$ willen houden

ludwig mack 2 januari 2008 13:26

quote:
Trader nr.1. schreef:
Deze gaat op de laagste koers ooit sluiten zo te zien ? en jaar low wat een bedrijf zeg,ik wil niet lullig doen maar ik denk dat het over en uit is hier.

je was dit vergeten, want alles heeft een reden:
2008 Prediction 31-Dec-07 02:17 pm
The stock price probably hit its low today with completion of tax loss selling. Positive news starting in the next few weeks should start to help lift the price.

ludwig mack 2 januari 2008 13:27

wish een mooie posting om het jaar mee te beginnen!
gr

quote:
The Wishbone schreef:
2008 Prediction 31-Dec-07 02:17 pm
The stock price probably hit its low today with completion of tax loss selling. Positive news starting in the next few weeks should start to help lift the price. The news events below should lift the stock to the $3 to $4 level by the end of 2008. If company provided research and clinical trials timeline are accurate it should be an even better year in 2009.

Upcoming news events:
1) US ATryn Phase 3 trial completion.
2) Annoucement of US ATryn partner in the U.S.
3) Announcement of partner in Japan
4) ATryn BLA for review
5) Announcement for ATryn partner for HD treatment (if not included in #2)
6) LEO European Phase II completion for ATryn for HD

Other potential stock movers:
1) Annoucement of CD 137 partnership
2) News from Merrimack Pharmaceuticals regarding its Phase II trial with drug produced by GTBC
3) Other new partnerships announced
4) New coverage of GTBC by brokerage houses as ATryn progresses through the approval process.

Sentiment : Buy

bron: tinylink.com/?OcnAtNG4PE

[verwijderd] 2 januari 2008 14:56

Gelukkig nieuwjaar voor iedereen met veel geluk en gezondheid.
Jan.

[verwijderd] 2 januari 2008 21:10

Interesting view of a former FDA's Office of Biotechnology expert (He was the medical reviewer for the first genetically engineered drugs evaluated by the FDA and was instrumental in the rapid licensing of human insulin and human growth hormone).

WILL REGULATION PREVENT ANIMAL BIOTECH FROM BRINGING HOME THE BACON?

www.nbiap.vt.edu/news/2008/news08.jan...

Henry I. Miller, M.D.

Biotechnology is everywhere these days, from the production of pest-resistant crops to microorganisms that make biofuels to new drugs and vaccines. It’s even being used to produce animals with novel and valuable traits, but these applications in particular are suffering from inconsistent, uncertain regulation. After 20 years, the FDA has not yet published a policy statement, but a senior official in its Center for Veterinary Medicine recently gave a strong hint of the agency’s preferred approach. She said that every new genetic construction in an animal that employs recombinant DNA, or gene-splicing, technology would require approval for use in the food supply, and that the applicable procedures and regulations would be the same as for drugs used to treat animal diseases.

But the introduction of a gene is not the same as the administration of a drug. Moreover, the FDA’s approach represents a major shift in FDA’s regulation of biotechnology that will be hugely expensive to animal breeders and detrimental to consumers. John J. Cohrssen, who worked on FDA reform during the 1990’s as majority counsel of the House Commerce Committee, characterized the FDA’s new approach as "complex, arbitrary and dilatory."

Up till now, the FDA has not regulated farm animals or, for that matter, animals used for what might be termed "medical purposes." For example, if German shepherds or golden retrievers were bred to enhance traits that made them better seeing-eye or companion dogs, the FDA would not regulate them under its medical device or veterinary drug regulations. Nor would a leaner line of pigs be regulated differently from others under the FDA’s food regulations, unless some safety issue was raised. Even for transgenic animals used in research, the FDA has not asserted jurisdiction over the hundreds of rodent lines that are available (http://www.criver.com/research_models_and_ services/transgenic_services/tgresearchmodels.htm).

The only transgenic animal currently marketed to the public at large is a small, tropical, ornamental (aquarium) zebrafish that glows because of the insertion and expression of a gene that synthesizes a beautifully colored fluorescent protein (http://www.glofish.com). The fluorescent protein genes were obtained from another marine organism, the sea anemone. The FDA opted not to regulate them, under this rationale: "Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply. There is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States. In the absence of a clear risk to the public health, the FDA finds no reason to regulate these particular fish."

That statement from the FDA would seem to weaken the argument for treating transgenic animals as though they were being treated with a "new drug." (It is noteworthy that in spite of the fact that the fluorescent fish are not eaten and would not survive outside an aquarium, they have been banned by regulators in California.) The most apposite models for gene-spliced or "transgenic" animals are the FDA’s oversight of traditional foods and food additives; and the production of livestock clones, or identical twins, which regulators decided last year were safe to eat.

A company called Aqua Bounty Technologies has been trying for about a decade to get FDA approval to market an Atlantic salmon that contains a newly introduced Chinook salmon growth hormone gene engineered to keep it turned on all year round (instead of during only the warmer months, as in nature). This cuts the time to marketable adult weight from 30 months to 18. The extra gene confers no detectable differences in the salmon’s appearance, taste, or nutritional value; it just grows faster. In spite of sufficient evidence that the fish is safe to eat and does not differ nutritionally from other Atlantic salmon, the FDA has kept the company treading water for almost a decade.

There are numerous other applications in various stages of R&D, including transgenic livestock with leaner muscle mass, enhanced resistance to disease, or improved use of dietary phosphorous to lessen the environmental impacts of animal manure. But if regulators don’t make appropriate regulatory decisions soon, the entire sector could virtually disappear.

One problem plaguing the FDA’s Center for Veterinary Medicine is that the "new drug" paradigm doesn’t fit transgenic animals well. A better model is the way that another FDA component, the Center for Food Safety and Nutrition, regulates other foods. The law places the burden of ensuring the safety of foods and food ingredients on those who produce them. It prohibits the adulteration (contamination) or misbranding (mislabeling) of food, but the agency does not inspect or evaluate food prior to its sale in shops, supermarkets, or restaurants. Rather, federal oversight relies on market surveillance, or post-marketing regulation, and the FDA takes action only if there is an apparent problem. This approach has worked quite well over many years.

The law does require a pre-marketing review for certain food-related products. These include most food additives — a class of ingredients that includes preservatives, emulsifiers, spices, sweeteners, and natural and synthetic flavors or colors, among others. In general, a food additive must be pre-approved if it becomes a component of or otherwise affects the characteristics of a food and it is "not generally recognized as safe (GRAS) by qualified experts for its intended use."

GRAS is an important concept: Before a new food additive is marketed, it is the responsibility of the producer to determine whether or not the substance is GRAS. The agency routinely reviews food additive applications for safety only when the substance in question has been determined not to be GRAS by the producer. If the producer determines that a substance is GRAS, only a notification of that decision to the FDA is necessary (which is then subject to agency review).

The FDA’s existing approach to biotechnology and to foods in general could be adapted easily to transgenic animals. Traditionally, in a logical application of transitivity, the combination of two GRAS substances is still GRAS. Similarly, because adding a GRAS gene to a GRAS organism is likely to yield a GRAS outcome, an FDA pre-marketing review would not be necessary for genetic constructions like the fast-growing salmon. But instead the FDA intends to treat every new animal as though it contains a "new drug," the evaluation of which can take many years even if there is minimal likelihood of harm.

The GRAS/food additive concept is relevant to "transgenic" animals because of the nature of the techniques. "Transgenic" animals usually are created by injecting the desired gene — which may be intended to confer an advantage in husbandry or nutrition, for example — into a single-cell embryo, or by inserting the gene into a skin cell and cre

sappas 3 januari 2008 09:44

quote:
crackedtooth schreef:
Interesting view of a former FDA's Office of Biotechnology expert (He was the medical reviewer for the first genetically engineered drugs evaluated by the FDA and was instrumental in the rapid licensing of human insulin and human growth hormone).

WILL REGULATION PREVENT ANIMAL BIOTECH FROM BRINGING HOME THE BACON?

www.nbiap.vt.edu/news/2008/news08.jan...

Henry I. Miller, M.D.

Beste Crackedtooth als ik dit artikel goed lees dan is dit niet gunstig voor GTCB.

Klopt dat?

Groetjes,

Sappas

[verwijderd] 3 januari 2008 10:03

de 6 in Nederland genoteerde biotech fondsen daalden vorig jaar met gemiddeld 33%.

en gtcb daalde vorig jaar van 1.10 naar 87 ct zijnde een luttele 22%

is dat even een meevaller. ( exclusief dollar-effect, inclusief 33%)

[verwijderd] 3 januari 2008 10:54

quote:
sappas schreef:
[quote=crackedtooth]
Interesting view of a former FDA's Office of Biotechnology expert (He was the medical reviewer for the first genetically engineered drugs evaluated by the FDA and was instrumental in the rapid licensing of human insulin and human growth hormone).

WILL REGULATION PREVENT ANIMAL BIOTECH FROM BRINGING HOME THE BACON?

www.nbiap.vt.edu/news/2008/news08.jan...

Henry I. Miller, M.D.
[/quote]
Beste Crackedtooth als ik dit artikel goed lees dan is dit niet gunstig voor GTCB.

Klopt dat?

Groetjes,

Sappas

Dacht ik ook eerst idd.
Maart de FDA ligt onder vuur vanwege al die beslissingen die maar op zich laten wachten, er moet meer snelheid komen. Probleem is wanneer komt die omslag?

[verwijderd] 3 januari 2008 15:43

1e twee minuten zagen er interessant uit....
daarna direct de kop ingedrukt,,,,
Harken maar!

[verwijderd] 3 januari 2008 16:33

probleem gtcb blijft hun transgenics
politiek dan ook een factor

[verwijderd] 4 januari 2008 00:49

quote:
crackedtooth schreef:
probleem gtcb blijft hun transgenics
politiek dan ook een factor

he gringo,wait until hillary becomes la presidente del utats unis

[verwijderd] 4 januari 2008 01:50

Straks democraat in het witte huis en dan keert het tij.

[verwijderd] 4 januari 2008 01:54

quote:
france schreef:
he gringo,wait until hillary becomes la presidente del utats unis

Hiermee ga ik volledig mee akkoord.
Het is algemeen geweten, dat republikeinen de pharmacie-sector steunt. We spreken dan wel over de (klassieke) reuzen. En om deze te beschermen ...
Misschien moten we ook daar de reden zoeken dat de FDA (nauwlettend in het oog gehouden door de govenment) heel moeilijk doet bij het goedkeuren van biopharmacie. (waar trouwens een groeiend protest voor is)
Ik lees hier ook regelmatig over het misnoegen van het steeds maar groter wordend kader (bestuur). Ik denk niet dat deze leden zich zouden inlaten met "vogels voor de kat".

Wie geduld heeft zal beloond worden.

Mvg

ps. Natuurlijk voor (bijna) iedereen een gelukkig en GEZOND jaar.

[verwijderd] 4 januari 2008 09:30

Komt goed. Kijk maar:

www.stock100.com/plotForecast.asp?sym...

[verwijderd] 4 januari 2008 12:41

gelukkig, begon me al zorgen te maken!

[verwijderd] 4 januari 2008 13:29

Cloned Livestock Poised To Receive FDA Clearance
By JANE ZHANG in Washington, JOHN W. MILLER in Brussels and LAUREN ETTER in Chicago
January 4, 2008; Page B1

Get ready for a food fight over milk and meat from cloned animals and their offspring.

After more than six years of wrestling with the question of whether meat and milk from them are safe to eat, the Food and Drug Administration is expected to declare as early as next week that they are.

The FDA had asked producers of cloned livestock not to sell food products from such animals pending its ruling on their safety. It isn't clear whether the FDA will lift this voluntary hold.

[verwijderd] 4 januari 2008 14:08

quote:
ohmygod schreef:
Cloned Livestock Poised To Receive FDA Clearance
By JANE ZHANG in Washington, JOHN W. MILLER in Brussels and LAUREN ETTER in Chicago
January 4, 2008; Page B1

Get ready for a food fight over milk and meat from cloned animals and their offspring.

After more than six years of wrestling with the question of whether meat and milk from them are safe to eat, the Food and Drug Administration is expected to declare as early as next week that they are.

The FDA had asked producers of cloned livestock not to sell food products from such animals pending its ruling on their safety. It isn't clear whether the FDA will lift this voluntary hold.

Tja zeg jij het of zeg ik het?

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