relavo
Forumer storico
ripropongo il fanta-tormentone..
domani non solo NicOx ha in previsione di emettere "comunicazioni"
in effetti.... coincidenza i movimenti del 18 e 15 Feb?
NicOx.... in attesa di.....
- Creatore Discussione DickSIM
- Data di Inizio
in effetti.... coincidenza i movimenti del 18 e 15 Feb?
magolibero
..se la sà gira..
+ al 31/12/10 => 17,9 M € di cassa
+ Orphan Drug => Gylbera in dirittura di arrivo in EU, in USA e in CAN
http://www.amtbiopharma.com/uploads/20110331-biocapital-presentation-amt-pdf_254.pdf
fra gli azionisti rilevanti anche CA
http://www.boursorama.com/profil/resume_societe.phtml?symbole=1rAAMT
..nel caso ti volessi divertire un qualche fanta-calcolo di fanta-M&A-concambio
magolibero
..se la sà gira..
in effetti.... coincidenza i movimenti del 18 e 15 Feb?
non saprei che dirti
- di grafici non ci capisco una mazza
- lo spunto della riflessione é farina del mio sacco
quello che ho scritto sono ulteriori considerazioni su di un post pubblicato su forum di AmCox nel periodo da te evidenziato , e che Zohar ha postato
QUI
simis
Encoxé à fond
ripropongo il fanta-tormentone..
domani non solo NicOx ha in previsione di emettere "comunicazioni"
chissa ...
http://www.ema.europa.eu/ema/index....ts/news_and_events.jsp&mid=WC0b01ac058004d5c3
tradermen
Forumer storico
+ al 31/12/10 => 17,9 M € di cassa
+ Orphan Drug => Gylbera in dirittura di arrivo in EU, in USA e in CAN
http://www.amtbiopharma.com/uploads/20110331-biocapital-presentation-amt-pdf_254.pdf
fra gli azionisti rilevanti anche CA
http://www.boursorama.com/profil/resume_societe.phtml?symbole=1rAAMT
..nel caso ti volessi divertire un qualche fanta-calcolo di fanta-M&A-concambio
difficile stabilirlo, cmq a questo punto urgono fatti non pugnette..x me meglio sarebbe che qualcuno si pappasse nicox..
magolibero
..se la sà gira..
simis
Encoxé à fond
Glybera® for LPLD has received orphan drug designation from the regulatory authorities in Europe and the United States. Due to the nature of the underlying disease and its low prevalence we do not expect that a competitive treatment will be developed which could prevent us from getting orphan drug status.
We are now working towards an official response to the Day 120 questions, due by the end of 2010. Assuming no unforeseen adverse events or delays, we expect to receive the opinion of the CHMP on our MAA mid 2011. If the CHMP's opinion is positive, a decision from the European Commission for marketing authorization is expected to follow approximately two months thereafter.
In various jurisdictions it is possible to allow patients in critical disease stages early access to innovative therapies which are still under regulatory review on the basis of a nationally approved "named-patient sales program". Assisted by a specialized consulting and sales company we have taken steps to implement a named-patient sales program in France, to make the product available to LPLD patients in need. Currently, we are collaborating with a panel of experts who are reviewing the available data against the patient population they care for, so they may propose early access to the French regulatory authority (Agence Française de Sécurité Sanitaire des Produits de Santé – AFSSAPS). We expect the first 'early access' patient in France will be dosed early in 2011, prior to the CHMP opinion on our MAA and the decision from the European Commission for marketing authorization.
We intend to also seek permission to market Glybera® in Canada and, later, in the US. Filing in Canada is anticipated for 2011. We expect to receive either special protocol advice in preparation for an investigational new drug (IND) application in the US in the course of 2011 or file a biological license application (BLA) for approval in the United States at the end of 2011 or early 2012. The eventual path forward in Canada and the United States will depend to a large extent on the opinion of the EMA.
We are now working towards an official response to the Day 120 questions, due by the end of 2010. Assuming no unforeseen adverse events or delays, we expect to receive the opinion of the CHMP on our MAA mid 2011. If the CHMP's opinion is positive, a decision from the European Commission for marketing authorization is expected to follow approximately two months thereafter.
In various jurisdictions it is possible to allow patients in critical disease stages early access to innovative therapies which are still under regulatory review on the basis of a nationally approved "named-patient sales program". Assisted by a specialized consulting and sales company we have taken steps to implement a named-patient sales program in France, to make the product available to LPLD patients in need. Currently, we are collaborating with a panel of experts who are reviewing the available data against the patient population they care for, so they may propose early access to the French regulatory authority (Agence Française de Sécurité Sanitaire des Produits de Santé – AFSSAPS). We expect the first 'early access' patient in France will be dosed early in 2011, prior to the CHMP opinion on our MAA and the decision from the European Commission for marketing authorization.
We intend to also seek permission to market Glybera® in Canada and, later, in the US. Filing in Canada is anticipated for 2011. We expect to receive either special protocol advice in preparation for an investigational new drug (IND) application in the US in the course of 2011 or file a biological license application (BLA) for approval in the United States at the end of 2011 or early 2012. The eventual path forward in Canada and the United States will depend to a large extent on the opinion of the EMA.
tradermen
Forumer storico
nn c'è regola fissa , dipende da diversi fattori, quando poi è minima i prezzi si adeguano il giorno dopo...
