Flamel Technologies (FLML) die neue Amylin !!
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| Eröffnet am: | 02.11.07 13:53 | von: Chalifmann3 | Anzahl Beiträge: | 67 |
| Neuester Beitrag: | 25.04.21 13:11 | von: Barbarayngra | Leser gesamt: | 15.009 |
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LYON, FRANCE--(Marketwire - Oct 18, 2012) - Flamel Technologies SA ( NASDAQ : FLML ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for an undisclosed hospital-based product. Flamel has received a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of May 31, 2013. For competitive reasons, the Company has decided not to identify the product at this time, but intends to provide additional information at a later date. Flamel believes that the product could have a significant impact on the company's revenue generation and favorably impact its progression to profitability. If approved by the FDA, the product is expected to generate approximately $25 million to $35 million or more in peak annual revenues, subject to the Company being able to market and price the product successfully, of which there can be no assurance.
"This NDA acceptance is an important milestone for our business and we believe it demonstrates the expanded capabilities of Flamel," said Michael S. Anderson, Chief Executive Officer. "This is the first of what we expect to be multiple new product applications to come from our internal pipeline over the next few years."
MFG
Chali
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Wertpapier: Flamel Technologies |
"We are extremely excited and pleased to receive this FDA approval for Bloxiverz™, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, Chief Executive Officer of Flamel.
Bloxiverz™ is the first FDA-approved version of neostigmine, even though other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938. Today, neostigmine is the most common agent used for the reversal of the effects of other agents used for neuromuscular blocks.
"Based on our marketing experience, we believe that hospitals will welcome the addition of Bloxiverz™ as an FDA-approved version of neostigmine," continued Mr. Anderson. "In addition, unapproved versions of neostigmine have been in short supply for nearly a year, which may add to the need for a reliable source of FDA-approved product."
Safety Information
The most common adverse reactions during treatment include bradycardia, nausea and vomiting. Atropine or glycopyrrolate should be administered prior to Bloxiverz to minimize the risk of bradycardia. Bloxiverz should be used with caution in patients with arrhythmias, recent acute coronary syndrome, vagotonia, hyperthyroidism, myasthenia gravis, epilepsy or peptic ulcer. Because of the possibility of hypersensitivity in an occasional patient, atropine and medications to treat anaphylaxis should always be readily available. Large doses of Bloxiverz administered when neuromuscular blockade is minimal can produce neuromuscular dysfunction. The dose of Bloxiverz should be reduced if recovery from neuromuscular blockade is nearly complete.
About Bloxiverz (neostigmine)
Bloxiverz (neostigmine) is a cholinesterase inhibitor that inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase at sites of cholinergic transmission. It enhances cholinergic action by facilitating the transmission of impulses across neuromuscular junctions. Neostigmine's ability to increase synaptic acetylcholine levels underlies its effectiveness in reversing neuromuscular blockade produced by neuromuscular blocking agents used during surgery. Neostigmine does not readily cross the blood-brain barrier and therefore does not significantly affect cholinergic function in the central nervous system
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Chali
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Wertpapier: Flamel Technologies |
Schau Dir einfach deren Pipeline an.
Dann lies Dir auch die s.a. Artikel durch, die letzten beiden.
Dann wirst Du sehen, dass sogar die 45 in den nächsten Monaten kein Problem werden sollt.
Alle Achtung!
Net schlecht.
Denke, dass auch die Käufer der letzten Tage genaustens wissen, warum.
Die Aktie ist ja irgendwie kaum bekannt: hier und bei wo sowieso nicht, und auf yahoo ebenfalls kaum posts.
Umso besser! Wenn die Masse kommt und wir bei 30-45 stehen, dann können wir ja immer noch verkaufen.
Negative Nachrichten habe ich soweit keine gefunden.
Oder versucht man hier wieder mal die kleinen rauszuschütteln?
Klar, Nasdaq war die Tage nicht prall, aber innerhalb von drei Tagen -25% ist schon derbe :(
Und wenn ich hier eure KZ lese, hoffe ich auf positiv anstehende News, bin leider erst recht spät auf die Aktie aufmerksam geworden.
.. ist noch nicht das Ende der Fahnenstange! Meine Meinung...
Stark!
Noch voll investiert.
Denke schon, dass wir die 30 sehen dieses Jahr und erst dann wird verkauft.
