NicOx.... in attesa di.....

caro vic anche dupont ora riduce il target da 20 a 12 euro,ormai e' bella che finita la storiella dei 18 che mi propinavi,ammettilo che hai toppato completamente e fossi in te due paroline al tuo amico ceo gliele direi.
per fortuna che era molmed quella che era la fonte di tutte le falsita' e le incapacita',hai proprio toppato alla grande.ma capisco quando uno si innamora di una persona diventa cieco.se questa cosa fosse accaduta a molmed ora staresti a riempire forum di qua e di la',invece su nicox due righe e basta e sarai di nuovo pronto a difenderla a spada tratta.
 
Ultima modifica:
July 22, 2016

No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene Bunod

FDA Letter Related to CGMP at Bausch + Lomb Facility

LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.


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August 07, 2017

LAVAL, Quebec, Aug. 7, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant will work closely with the FDA to determine the appropriate next steps for the NDA.
 
July 22, 2016

No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene Bunod

FDA Letter Related to CGMP at Bausch + Lomb Facility

LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.


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August 07, 2017

LAVAL, Quebec, Aug. 7, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant will work closely with the FDA to determine the appropriate next steps for the NDA.

gia' se in 1 anno non sono riusciti a risolvere il problema la cosa mi sembra critica
 
Non c'è che dire: siamo proprio sfortunati. Siamo incappati in soci che non rispettano le regole e ne stiamo pagando care le conseguenze.

piu' che soci pagate un management non all'altezza per il passato e ora incappate anche in soci che magari .....stanno facendo giochi con gli amici fondi usa che ben sapevano di questa lettera e cio' lo si vedeva nei movimenti degli ultimi mesi che solo qui vi ostinavate a non capire.
si diceva che era un titolo da 18 euro a brve,spero che nessuno abbia seguito tale consiglio,e ora gia' Dupont abbassa il target a 12
 
July 22, 2016

No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene Bunod

FDA Letter Related to CGMP at Bausch + Lomb Facility

LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.


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August 07, 2017

LAVAL, Quebec, Aug. 7, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant will work closely with the FDA to determine the appropriate next steps for the NDA.

A questo punto dovrebbero comunicare le motivazioni esatte,rendere noto ai soci il perche' di questo ulteriore rinvio altrimenti in futuro si potrebbero esporre annche a cause legali da parte degli stessi.perche' non mi sembra corretto tenerli all'oscuro dei motivi.
 
certo che ora a 10 EURO un entrata con target 12 e' da farsi.MA SOLO E SOLTANTO IN OTTICA BREVISSIMA PERCHE' SUL LUNGO NON MI FIDO PIU' AL 100%,QUESTO SECONDO RINVIO PUZZA NON POCO MA MOLTISSIMO,LE MOTIVAZIONI NON CI SONO E QUESTO RENDE IL TUTTO MOLTO GRAVE.L'HO SEMPRE DETTO NEI MIEI POST PRECEDENTI CHE I MOTIVI SU TAMPA NON SONO DI POCO CONTO,NON CI VUOLE PIU' DI UN ANNO PER FATTI DI LIEVE ENTITA'.LI CHIARISSERO SE VOGLIONO FAR TORNARE FIDUCIA SUL TITOLO.
 

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