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GTCB - GTC Biotherapeutics - Deel 12

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Omlaag ↓

ludwig mack 20 januari 2009 16:34

ik neem aan dat er een gesprek geweest is waar de verschillende partijen om te tafel hebben gezeten, en de fransen als de de enige partij bleek die er aanvullend geld in wilde steken, voor de k.t.; dat heeft de druk op de denen vergroot tot een concessie, zie daar mijn scene hoe het geaan is.
gr

[verwijderd] 20 januari 2009 16:43

iemand nog een rt koersen site?
deze doet het niet meer
www.nasdaq.com/aspx/nasdaqlastsale.as...

[verwijderd] 20 januari 2009 21:05

finance.google.com/finance?q=gtcb

realtime.

[verwijderd] 21 januari 2009 14:16

BIOTHERAPEUTICS REGAINS COMPLIANCE WITH NASDAQ
MARKETPLACE RULE 4310

FRAMINGHAM, MA – January 21, 2009 -- GTC Biotherapeutics, Inc. ("GTC" or “the Company”, NASDAQ: GTCB) received notice from the Listing Qualifications Staff (“Staff”) of The NASDAQ Stock Market indicating that GTC has regained compliance with the minimum market value of listed securities requirement for continued listing on The NASDAQ Capital Market, as set forth in Marketplace Rule 4310 (c)(3), by exceeding $35 million of market capitalization for 10 consecutive trading days. Based on NASDAQ’s recent extension of the temporary suspension of Marketplace Rule 4450(a)(5), GTC has until at least July 20, 2009 to regain compliance with the minimum $1.00 bid price requirement for continued listing.

“We are pleased to have regained compliance with the minimum market capitalization listing requirement,” stated Geoffrey F. Cox, GTC’s Chairman of the Board and CEO. “We look forward to continuing to build on our strengths with expected near term news regarding ATryn’sregulatory review and its commercial launch in the USA.”

ATryn®, GTC’s recombinant form of human antithrombin, was recently recommended by the Blood Products Advisory Committee, or BPAC, to be safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The Food and Drug Administration, or FDA, instituted guidance last week regarding the review and approval of a New Animal Drug Application, or NADA, for animals that incorporate additional genetic information. GTC worked closely with FDA staff to present all relevant information and participated in all field inspections necessary to support the review of an NADA for the animals that produce recombinant human antithrombin in their milk. The FDA’s preliminary review of this information was presented to the BPAC. Under the Priority Review process, the target action date for a decision by the FDA on the Biologics License Application for ATryn® is February 7, 2009. OVATION Pharmaceuticals, GTC’s partner for development and commercialization of ATryn® in the United States, is planning for commercial launch of the product following FDA approval.

orchid 21 januari 2009 14:16

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC" or “the Company”, NASDAQ: GTCB) received notice from the Listing Qualifications Staff (“Staff”) of The NASDAQ Stock Market indicating that GTC has regained compliance with the minimum market value of listed securities requirement for continued listing on The NASDAQ Capital Market, as set forth in Marketplace Rule 4310 (c)(3), by exceeding $35 million of market capitalization for 10 consecutive trading days. Based on NASDAQ’s recent extension of the temporary suspension of Marketplace Rule 4450(a)(5), GTC has until at least July 20, 2009 to regain compliance with the minimum $1.00 bid price requirement for continued listing

[verwijderd] 21 januari 2009 15:02

Op naar de 30 dagen boven de $1 en dan zijn de delisting perikelen voorbij. Is er ook geen reverse split nodig en kunnen we weer eens rustig ademhalen.

Mvgr,

BB

[verwijderd] 21 januari 2009 17:39

Hebben we de stijgende lijn weer te pakken?
0,70

orchid 21 januari 2009 18:12

Ja,ja,

Er komen grote blokken voorbij, het patroon van Gtcb is nu openen met de daytraders en kleine kopers ( zakken dus ),dan na een tijdje een paar grote kopers die de zaak in beweging zetten.

met 50 k blokken gaan we wel omhoog, verder zie je ook aan de onderkant blokkades, nu op 68 cent een blok om dumpen tegen te gaan.

Sluiting blijft kwetsbaar en belangrijk.

elke dag een stukje omhoog. :))

jurpsy 23 januari 2009 12:11

Drugs from genetically engineered poised to debut in U.S.
by Kristen Minogue
Jan 22, 2009

Medication from genetically engineered animals could appear as early as next month if, as anticipated, the Food and Drug Administration approves ATryn, a blood thinner made from the milk of genetically engineered goats.

An FDA committee gave a green light to the drug, manufactured by Framingham, Mass.-based GTC Biotherapeutics, on Jan. 9. The European Commission already approved the drug in August 2006, and the FDA could formally approve it for sale in the U.S. as soon as Feb. 7.

If the agency approved it, the drug could help treat patients with a rare blood-clotting disorder called hereditary antithrombin deficiency.

ATryn is just one of several drugs from gentically engineered animals that could start appearing on the market soon.

“Transgenic animals are probably going to be the drug stores of the future,” said biologist Bryan Pickett, who works with genetically engineered zebra fish at Loyola University of Chicago.

The FDA guidelines for such drugs, released on Jan. 15, outlined a much more stringent review process for genetically engineered animal products than cloned animal products. Unlike clones, which are supposed to be genetically identical to animals that already exist, genetically engineered animals have DNA from other organisms, often other species, inserted into their genome. Milk and meat from cloned cows, pigs and goats received a blanket approval from the FDA in January 2008.

The FDA evaluates every different "recombinant DNA construct "– foreign DNA inserted into an animal – on a case-by-case basis. Developers who want to market products from transgenic animals have to submit a new animal drug application to the FDA. Approval can take up to 10 months.

So far the only genetically engineered animals for sale in the U.S. are a glow-in-the-dark zebra fish sold in pet stores and laboratory animals like mice. The FDA hasn’t received any applications for genetically engineered meat.

Consumers are wary of the new technology. Of the 28,000-plus comments the FDA received on the draft guidelines last fall, the overwhelming majority opposed genetic engineering.

But that isn’t stopping developers, according to University of Illinois at Urbana-Champaign biologist Matthew Wheeler, who co-authored a report on the animals’ potential benefits last June.

Wheeler's report showed genetically engineered animals are popping up in dozens of sectors, including:

 New Medicines – ATryn may become the first transgenic animal-produced drug to hit U.S. markets, but it’s not the only one that’s been developed. Researchers have created milk from genetically engineered sheep and pigs that can treat a rare type of hemophilia. Another strain of genetically altered pigs secretes milk with a hormone to help anemia patients produce more red blood cells.

 Eco-friendly Animals – Researchers created the Enviropig in 2001, a pig that can excrete 60 percent less phosphorus than normal pigs, reducing pollution. Scientists at the National University of Singapore engineered the GloFish, a fluorescent zebra fish now sold in the U.S., to detect water pollution.

 Human-Animal Transplants – Some have greeted this as the solution to the organ shortage problem. Transgenic pig hearts have lasted in baboons for up to six months. Researchers also hope insulin-producing pig cells could help diabetes patients and transgenic pig livers could act as temporary transplants while patients wait for permanent replacements.

 Animal Health – Genetically engineered dairy cows are already able to begin resisting mastitis, an infection that decreases milk production, by secreting the bacteria-killer lysostaphin into their milk. Other possibilities include creating cows resistant to mad cow disease and brucellosis, a bacterial disease that can be transferred to humans.

Pickett said the risk of releasing potentially dangerous genetic materials is very low. But at the same time he respects the FDA’s regulation.

Meanwhile researchers are trying to calm any fears consumers may have about genetic engineering.

“I think all scientists really are for responsible, compliant and responsible, drug policy,” Pickett said.

news.medill.northwestern.edu/chicago/...

[verwijderd] 26 januari 2009 15:03

nou laat de goed nieuws show maar beginnen ,
koersdoel boven de euro

[verwijderd] 26 januari 2009 15:21

quote:
vlielander schreef:
nou laat de goed nieuws show maar beginnen ,
koersdoel boven de euro

en dat mag ook wel voor de LT'ers.

Pre-Market: 0.700 +0.020 (2.94%) - Jan 26, 8:03AM EST NASDAQ Real-time data - Disclaimer

mijn koersdoel op goedkeuringsdag 1,60 dollar.
dus iets meer dan die euro ? Vlielander !

orchid 26 januari 2009 16:37

Koers is nu gevangen tussen 68 en 69 cent.

Blijkbaar is er belang de koers daar voorlopig te laten, duidelijk controle.

Alleen grote blokken kunnen dit doorbreken, die zijn er ( nog ) niet.

Voor de 7'zijn we veel hoger denk ik, ben benieuwd wanneer grote beleggers instappen.

Volume moet echt vele miljoenen zijn, dan gebeurd er wat. ( nu ong. een miljoen stuks.)

[verwijderd] 26 januari 2009 17:10

bloggingstocker.blogspot.com/2009/01/...

[verwijderd] 26 januari 2009 17:17

goed gevonden ,

The Weekly Top 5: Bio Pharmaceutical Microcap Stocks To Watch
Week Of January 26-January 30
(2009)

GTC Biotherapeutics (GTCB): Company is awaiting approval from the FDA per its transgenic goat-based ATryn® drug. In an historic move, an FDA advisory committee recently endorsed the drug. The FDA decision is due by February 7, 2009. Pharma drugs made from/with genetically-engineered animals is a hot topic, and related final guidelines from the FDA have recently been issued- in anticipation of the Obama administration's pro-stem cell agenda.

[verwijderd] 26 januari 2009 17:47

Volume is inderdaad nog te gering om definitief door de 70 te breken.
Maar, als ie door de 70 gaat loopt de koers vermoedelijk ook wel door tot ergens in de 80. Om vervolgens weer even te blijven hangen.
Hoop echt dat dit scenario nog deze week plaats vindt. Dan is de uitgangskoers voor verdere stijging volgende week en bij goedkeuring ook weer een stukkie prettiger.

[verwijderd] 26 januari 2009 17:51

"The FDA decision is due by February 7, 2009."

By the way: ik neem aan dat vrijdagmiddag ET oftewel vrijdagavond 6 januari hier, de uitslag wel bekend zal zijn!?

[verwijderd] 26 januari 2009 18:18

ik zie het eerder zo gebeuren :
eerst week van feb een pb van gtcb dat de fda meer gegevens nodig heeft -> koers naar beneden
grote jongens kopen weer goedkoop in naar tweede uitspraak toe

[verwijderd] 26 januari 2009 18:19

Uit de FDA briefing van 9 januari 2009:

-The two studies conducted with ATryn, when pooled together, show that Atryn is as effective as plasma derived ATIII in preventing peri-operative and peri-partum thromboembolism in congenital ATIII deficient patients when analyzed by prespecified statistical parameters and methods"

-"Immunogenicity:
No patients developed anti ATIII antibodies. Data on repeat exposure to the product is very limited and is being evaluated in post marketing studies."

CONCLUSIONS

ATryn has been shown to be efficacious, using the recommended dosing guidelines, for prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Careful monitoring of AT activity levels during treatment is recommended. The safety profile appears to be acceptable.

www.fda.gov/ohrms/dockets/ac/09/brief...

[verwijderd] 26 januari 2009 18:29

quote:
mediaseller schreef:
ik zie het eerder zo gebeuren :
eerst week van feb een pb van gtcb dat de fda meer gegevens nodig heeft -> koers naar beneden
grote jongens kopen weer goedkoop in naar tweede uitspraak toe

Ik zou zeggen: lees de complete FDA briefing van 9 januari en overtuig je zelf ervan of de FDA meer gegevens nodig heeft.
Uiteraard wil de FDA dat er meer immunogegevens verzameld worden maar dat gebeurt na het op de markt brengen van ATryn.
Niet onbelangrijk: Atryn wordt gebruikt bij bevallingen,kan dus moeilijk veelvuldig getest worden en is (voor deze toepassing) ook niet bedoeld voor veelvuldig gebruik.

Of de FDA volgende week dus meer gegevens nodig heeft: ja,immunogegegevens maar die staan een goedkeuring volgende week NIET in de weg!!

[verwijderd] 26 januari 2009 18:33

ik hoop echter ook hoor dat er voor 7feb een pos uitspraak komt. (heb er ook een paar 1000den)
mijn ervaring met andere biofondsen heeft me reeds meerdere keren het tegendeel bewezen, vandaar mijn twijfel

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