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GTCB - GTC Biotherapeutics - Deel 11

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quote:

crackedtooth schreef:

[quote=france]
je kan er ook geen lijn op trekken wat die bio's waard moeten zijn.

neem nu eens het bedrijf idenix ( IDIX ),

wat aan het klooien met clinish fase 1 en fase 2

omzet van 1e half jaar 08 nog geen 4 miljoen en

de tent is bijna een half miljard waard.

4 keer over de kop de laatste maanden naar 8.50.

kijk maar eens op finance, genoeg info.

verder zal hewt jullie niet verbazen dat gtcb technisch is uitgebroken, voor wat dat waard is.

neergaande trendkanaal overtuigend verlaten, zorgt niet zelden voor een paar honderd procent koersstijging.

mvg, long time.
[/quote]

doe het nu eens zonder het mindloze gepump

"neergaande trendkanaal overtuigend verlaten, zorgt niet zelden voor een paar honderd procent koersstijging. "

vlieg toch op man

idd bullish reversal op DAILY chart,
weekly nog lang niet

sjonge jonge...triest hoor
daily, weekly, monthly, yearly, whatever, fact is dat er een begin is gemaakt met zoiets als een uitbraak, en maar dat heb ik hier al vaker gezegd.

ik zit erin voor de lange termijn, not for a day a week.........etc

fundamenteel is er in ieder geval sprake van een overtuigende uitbraak en daar gaat het mij om.

mvg, little paraquaio, broer van fladder fladder.
ludwig mack
0
Laatste 0,6800 15:30 1.900
+/- 0,06 9,68%
Slot 0,6200 11-08-08
Open 0,6500 15:30
Hoog 0,6800 15:30
Laag 0,6500 15:30
Bied
Laat
Volume 7.000
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Klopt france, het ziet er allemaal goed uit. LT al helemaal.
Dahag handelaren :-).
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0
64 ct nu bij een modest omzet van 84.000 st.

het fonds wordt in ieder geval in het begin niet inkaar getrapt.

61 laag een paar aandelen op 68 hoog.

huidig 64 centen.

belachelijk natuurlijk.
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Durfinvest schreef:

Ben bang dat het gemodder weer van voor af aan begint hier,gisteren vanaf 0,76 begon men weeral,men drukte em terug naar 0,62,het manipuleren begon alweer,ik ken ze.
Laatste koers Verschil


0.59 USD -0.03 (-4.84 %)
Bid Ask
0.58 0.59
Bid Quantity Ask Quantity
100 300
Volume Tijdstip
268994 2008-08-12 17:10:02
Slotkoers Openingskoers
0.62 0.65
Laagste v/d dag Hoogste v/d dag
0.56 0.68
_____________________________________ Ik riep het he ! ,0.59 en dalende !
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quote:

Durfinvest schreef:

[quote=Durfinvest]
Ben bang dat het gemodder weer van voor af aan begint hier,gisteren vanaf 0,76 begon men weeral,men drukte em terug naar 0,62,het manipuleren begon alweer,ik ken ze.
[/quote]Laatste koers Verschil


0.59 USD -0.03 (-4.84 %)
Bid Ask
0.58 0.59
Bid Quantity Ask Quantity
100 300
Volume Tijdstip
268994 2008-08-12 17:10:02
Slotkoers Openingskoers
0.62 0.65
Laagste v/d dag Hoogste v/d dag
0.56 0.68
_____________________________________ Ik riep het he ! ,0.59 en dalende !
Niet zo zeuren, Durf-Almighty, zijn gewoon trading-differences.
Winstnemers en weer instappers.

L*lkoek, ik ken ze......

Ik heb er weer een paar ingeslagen op 59, eigenlijk wat te laat.

Jay
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quote:

Durfinvest schreef:

Ik riep het he ! ,0.59 en dalende !
[/quote]

[quote=JaySS]
Niet zo zeuren, Durf-Almighty, zijn gewoon trading-differences.
Winstnemers en weer instappers.

L*lkoek, ik ken ze......

Ik heb er weer een paar ingeslagen op 59, eigenlijk wat te laat.

Jay
Ah jay, is het dan ook de enige hier op dit forum die het geluk heeft, een glazen bol te bezitten.
Hij is vast al gefortuneerder dan Warren Buffett, lees ik hier links en rechts ...!
Hoorde het eveneens van een Amerikaanse kennis.
~~ giggle ~~
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quote:

SkySpam1 schreef:

[quote=Durfinvest]
Ik riep het he ! ,0.59 en dalende !
[/quote]

[quote=JaySS]
Niet zo zeuren, Durf-Almighty, zijn gewoon trading-differences.
Winstnemers en weer instappers.

L*lkoek, ik ken ze......

Ik heb er weer een paar ingeslagen op 59, eigenlijk wat te laat.

Jay
[/quote]
Ah jay, is het dan ook de enige hier op dit forum die het geluk heeft, een glazen bol te bezitten.
Hij is vast al gefortuneerder dan Warren Buffett, lees ik hier links en rechts ...!
Hoorde het eveneens van een Amerikaanse kennis.
~~ giggle ~~
Op Yahoo MB zeggen ze ook dat hij er verstand van heeft.

Tja, dan moet het wel waar zijn, kom we springen hem achterna.

Jay
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vandaag 100k buy volume, 340k sell volume
volgens ihub tickerlist
betekent niets anders dan dat er 100k vanauit de laat is gekocht
en 340k op de bied is verkocht
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Tuesday, August 12, 2008 - 1:57 PM EDT

GTC partnerships improve financialsBoston Business Journal - by Mark Hollmer Boston Business Journal
Print Email Reprints RSS Feeds Add to Del.icio.us Digg This CommentsDrug development partnerships helped GTC Biotherapeutics Inc. drastically reduce net losses during its fiscal 2008 second quarter.

The Framingham, Mass. company (Nasdaq: GTCB) lost $2.2 million during the quarter ending June 29, compared to a $10.6 million loss in the fiscal 2007 second quarter.

Chairman and CEO Geoffrey Cox said in a statement that the strong numbers were generated by funds from the company’s drug development partnerships.

Among them: GTC has signed a deal with Ovation Pharmaceuticals to commercialize and further develop the drug ATryn in the U.S.

The deal, worth $3 million up front, could be worth more than $257 million assuming development milestones are met.

ATryn is an anti-clotting agent.

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SkySpam1 schreef:

Tuesday, August 12, 2008 - 1:57 PM EDT

GTC partnerships improve financialsBoston Business Journal - by Mark Hollmer Boston Business Journal
Print Email Reprints RSS Feeds Add to Del.icio.us Digg This CommentsDrug development partnerships helped GTC Biotherapeutics Inc. drastically reduce net losses during its fiscal 2008 second quarter.

The Framingham, Mass. company (Nasdaq: GTCB) lost $2.2 million during the quarter ending June 29, compared to a $10.6 million loss in the fiscal 2007 second quarter.

Chairman and CEO Geoffrey Cox said in a statement that the strong numbers were generated by funds from the company’s drug development partnerships.

Among them: GTC has signed a deal with Ovation Pharmaceuticals to commercialize and further develop the drug ATryn in the U.S.

The deal, worth $3 million up front, could be worth more than $257 million assuming development milestones are met.

ATryn is an anti-clotting agent.

Moet jij nog niet naar bed joh,je moeder roept !
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Laatste koers Verschil


0.58 USD -0.02 (-3.33 %)
Bid Ask
0.58 0.60
Bid Quantity Ask Quantity
100 5000
Volume Tijdstip
8100 2008-08-13 15:30:00
__________________________________Het gemodder hier is weer gewoon begonnen zoals te verwachten viel.
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Hahahaaha scaretodeadinvest,waar komen ze vandaan????
Gezond aantal winstnemers.
Je moet niet overal wat achter zoeken,tenzij een smalle horizon + tunnelvisie.

Vriendelijke groet.
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Durfinvest schreef:

Laatste koers Verschil


0.58 USD -0.02 (-3.33 %)
Bid Ask
0.58 0.60
Bid Quantity Ask Quantity
100 5000
Volume Tijdstip
8100 2008-08-13 15:30:00
__________________________________Het gemodder hier is weer gewoon begonnen zoals te verwachten viel.
je bent zelf modder!
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quote:

Durfinvest schreef:

Het gemodder hier is weer gewoon begonnen zoals te verwachten viel.
[/quote]

[quote=france]
je bent zelf modder!
Laat het uit, connect, hij is met de Noorderzon verdwenen. Maar niets dat zegt, dat ie hier morgen onder een andere alias terug is!
Maar hiervan was je waarschijnlijk, al wel van op de hoogte?
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Geoffrey Cox – GTC Biotherapeutics – CEO

This has been an excellent quarter for our business. We realized strong cash receipts from our partners, we've also secured an outstanding partner with Ovation Pharmaceuticals for the commercialization and further development of ATryn in the United States and we've completed the preparation of the final part of our rolling BLA submission. These are all great examples of GTC's progress in its strategic, operational and financial performance goals.

So let me take you through these in some more detail.

We have now completed preparing the second and final section of our rolling BLA submission that includes all the analyzed clinical data from our US study together with the data from our previous European study. We will be issuing a press release announcing submission to the FDA later today once the FDA receives all the data [#msg-31302703].

In February of this year we announced successfully meeting the non-inferiority end point of our US Phase III study for the prophylactic treatment of hereditary antithrombin deficient patients undergoing surgery or childbirth.

This study was composed of 17 evaluable patients treated with ATryn combined with the 14 that were treated in the European study and compared to an historical or retrospective control arm of 37 patients that have been treated with plasma-derived products for surgery or childbirth procedures. We submitted the first part of the rolling BLA at that time.

The first portion of the BLA filing led to the FDA's field inspections of our production pharm operations and the downstream purification of the Lonza facilities in Hopkinton, Massachusetts. We did not receive any major findings from these inspections.

Completing the BLA submission is a tremendous accomplishment for GTC particularly since it was achieved with our own clinical and regulatory staff. If you recall, we worked through the European regulatory process primarily through contract regulatory resources. This demonstrates our growing expertise and capability in successfully managing our own clinical and regulatory affairs.

Compared to our filing in Europe, which was submitted entirely on paper, this submission is a cross-linked electronic file that enables review or to more easily access all the data. This should assist in the timely review of our submission.

You'll remember towards the end of last year ATryn was designated an orphan drug and was also granted fast-track review. As a result of our fast-track status we have requested priority review and anticipate a decision from the FDA on this request as they review the complete BLA filing [#msg-31288224].

Assuming that priority review is granted, the FDA's decision on the BLA is anticipated six months after their acceptance of our filing. We're expecting an advisory panel meeting as part of this review as is the normal course of business for the FDA with products derived from [new] technology [#msg-29145593].

A key element of our growth strategy is to build financial value in ATryn by expanding development both geographically as demonstrated by the BLA submission, and importantly into much larger acquired antithrombin deficiency indications beyond the initial genetic deficiency submitted to the regulatory agencies for initial approval [#msg-29022959].

We have now come a very long way in realizing the strategy first through our partnership with LEO Pharma for Europe, Canada and the Middle East and now with Ovation Pharmaceuticals for the United States. LEO and Ovation both bring tremendous market expertise in their respective territories for commercially introducing the benefits of recombinant antithrombin while preserving the pricing power for the acquired deficiency indications.

Ovation is an important new partner [#msg-30191066]. Headquartered in Deerfield, Illinois, Ovation is a private company primarily backed by the private equity firm GTCR Golder Rauner, LLC.

Ovation focuses on drugs for high need patient groups that historically have not been well served by pharmaceutical innovations. Ovation was formed in 2000 and its senior executives have been drawn from major pharmaceutical companies such as Abbott, Baxter and Hospira. We understand that they have been profitable throughout their history with 85% compound annual growth in revenue and cash flow.

Importantly, for the development of ATryn, Ovation has a hospital-based sales force with a hematology and oncology biologics portfolio; they market Panhematin for the treatment of recurring attacks of porphyria, a genetic disorder, and Elspar, an E. coli-derived form of the enzyme asparaginase for the treatment of acute lymphoblastic leukemia. Ovation also works in the area of neonatal intensive care.

Ovation has a total of about 250 employees and has been recognized with the 2007 Chicago Innovation Award and as the Scrip Pharma Company of the Year in 2006 and 2007 in the under $5 billion revenues category.

Ovation will be responsible for ATryn's US launch including all sales and marketing. The agreement with Ovation provides that they will fund the anticipated clinical work for ATryn and heparin-resistance and pay us for the product used in the studies.

For the commercial sales, our average effective royalty percentage including the margin on our transfer price and the licensed royalty on sales will be in the low-20s. [This is an average rate over the life of the collaboration: #msg-30252905.]

In addition to the ongoing revenue from product sales, our agreement includes a series of potential clinical, regulatory and sales milestone totaling $257 million [#msg-30253171]. This includes payments of $9 million for the initial hereditary deficiency indication which consists of $3 million per closing of the agreement, $2 million for the acceptance of our BLA filing for hereditary deficiency and the successful determination of priority review and $4 million for approval in hereditary deficiency.

The closing of the agreement with Ovation remains on track although this has taken a little longer than originally anticipated. The required Hart-Scott-Rodino Review has been successfully completed and the legal requirements for closing are in the process of being completed.

Ovation's first interest is in developing the heparin-resistant indication that GTC has previously studied [#msg-30546734]. Heparin-resistance is the term applied to patients undergoing a cardiopulmonary bypass, or CPB procedure, who no longer respond satisfactorily to additional heparin.

As you may recall, heparin depends on the presence of antithrombin to have an anti-coagulant effect. Heparin is used in bypass procedures to minimize the risk of clot formation while the patient is on the bypass machine. Heparin-resistance occurs in up to 15% to 20% of CPB operations and we estimate the fully developed market in the US to be approximately $150 million.

The initial data GTC previously developed will be valuable in establishing an agreed protocol with the FDA. We plan, together with Ovation, to discuss our clinical study proposal with the agency after the review of the hereditary deficiency indication is complete. [Doing this sooner would be risky: #msg-30553183.]

While we'll have a better understanding of timelines after discussion with the FDA, it is possible that the heparin-resistance clinical program can begin later in 2009.

Ovation is also interested i
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quote:

Durfinvest schreef:

Ben bang dat het gemodder weer van voor af aan begint hier,gisteren vanaf 0,76 begon men weeral,men drukte em terug naar 0,62,het manipuleren begon alweer,ik ken ze.
Laatste koers Verschil


0.57 USD -0.03 (-5 %)
Bid Ask
0.57 0.57
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4400 4200
Volume Tijdstip
126479 2008-08-13 21:58:19
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0.60 0.58
Laagste v/d dag Hoogste v/d dag
0.57 0.59
_________________ klopte aardig.
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quote:

Durfinvest schreef:


In de Koffiekamer

Durfinvest schreef:

Ik kap er helamaal mee hier,zoek het maar uit !
Durfinvest - 13 aug 08, 17:43
[/quote]

[quote=Durfinvest]

Durfinvest schreef:
...,ik ken ze.
Durfinvest - 13 aug 08, 21:59

En het liegen en bedriegen gaat rustig verder!!

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rac69 schreef:

het is weer een bloedbad aan het worden hier.hahahaha loop naar de maan sky.
Wat zijn we weer lekker vriendelijk tegen elkaar?
Geloof aan de postings te zien dat er niemand is die een gulden kan verdienen!
Men zegt wel; in het verleden behaalde resultaten bieden geen garantie voor de toekomst.
Echter dat geld niet voor de verdraagzaamheid onder beleggers....

Lees de prospectus.
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