walberga2
N° messaggi: 5599 -
Iscritto da: 25/9/2010
enzo x amda sett positiva
min 0.5600 min max 0.550 ,,,,,
2 di 3906-06/7/2015 08:510
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Ok thanks wall
3 di 3906-06/7/2015 09:090
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Ormai imminente approvazione FDA
4 di 3906-06/7/2015 09:480
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Grazie per apertura forum
5 di 3906-06/7/2015 12:290
walberga2
N° messaggi: 5599 -
Iscritto da: 25/9/2010
Ok Ciao
6 di 3906-06/7/2015 22:240
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Wal occhio a domani, visti i grandi movimenti in chiusura
7 di 3906-06/7/2015 22:530
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Cup & Handle è quasi formata , ci muoveremo più in alto da qui , grafico molto rialzista
8 di 3906-06/7/2015 23:130
walberga2
N° messaggi: 5599 -
Iscritto da: 25/9/2010
0,90 , lo. Deve fare ,,, nelle prs sett ,, ciao
9 di 3906-06/7/2015 23:210
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Wal siamo a 0, 59 ( partiti da 0, 30) , e ci stiamo avvicinando a 1 $ che secondo nasdaq deve essere mantenuto per almeno 10 gg. FDA approvazione, 05/08 Q2 2015 e per finire 18/08 Nasdaq 1 $
10 di 3906-07/7/2015 13:440
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Personal experience......I've worked in the medical device industry 20 years. The companies I've worked for have done it. We would build up inventories and have pending orders ready, meaning we have a list doctors who want specific sizes and models of product. But we coudn't process orders in our systems until the clearance comes through. The same day we usually received the clearance letters, all the pending orders would be entered in the sales system. the product would already be sitting on the shelf and we could start fulfilling orders the same day. FDA allows medical device companies to build up as much product as they want but they cannot take ANY orders for product until the clearance is in hand. The companies can do so but it is at risk though, because during the course of the 510(k) review with FDA, FDA may come back and ask for something to be changed which could be a significant impact depending on how much product has been built up.
But I think nothing to worry about yet at this point. I think FDA may have gotten backed up during this past holiday week and the clearance should be coming soon.
11 di 3906-07/7/2015 14:420
Darkgothic
N° messaggi: 1633 -
Iscritto da: 12/5/2015
Ottime prospettive. In questo periodaccio poi vale doppio.
12 di 3906-08/7/2015 02:040
walberga2
N° messaggi: 5599 -
Iscritto da: 25/9/2010
siamo sui min sett sotto modifica il trend sett ..se dovesse scendere sotto 0.55
13 di 3906-08/7/2015 08:210
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced that responses to the U.S. Food and Drug Administration ("FDA") inquiries regarding the Company's cervical composite silicon nitride interbody device were submitted to the FDA on June 30, 2015. Additionally, the Company has received feedback from the FDA regarding its wear testing femoral head protocols.
Submission for 510(k) clearance of the Valeo C Interbody with CsC Osteo-Conductive Scaffolding ("Valeo C CsC"), which was submitted in the first quarter of 2015, relates to the Company's CASCADE clinical trial of its composite silicon nitride spinal interbody devices. Since submission, the Company received a list of questions from the FDA requesting additional information pertaining to the product's clinical performance data, as well as indications for use and device description. The Company has responded to the questions and now awaits clearance of the Class II medical device for commercial distribution or additional communication from the FDA.
"After successfully completing an important surveillance audit with no non-conformities being identified, we've submitted responses to the FDA questions regarding our composite silicon nitride device," said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. "Our submission starts the clock once again with the FDA, and we remain hopeful for a final response during the third quarter of this year. As sales momentum of this unique device continues to build in Europe, we look forward to beginning domestic shipments as soon as we achieve clearance."
"We also received very constructive feedback on our proposed wear testing protocol and have a clearer understanding of the pathway to market for our silicon nitride femoral heads in the U.S.," continued Dr. Bal. "The comments by the FDA will ensure that the testing of our material, as compared to other ceramic predicate devices on the market, will meet or exceed existing testing standards. Silicon nitride is the toughest, most fracture resistant, chemically stable bioceramic available today. We look forward to a direct comparison to all other femoral head materials, which is slated to begin later this year, to confirm our claim that silicon nitride is the ideal biomaterial of choice."
Tempi si allungano, ma le prospettive sembrano incoraggianti
14 di 3906-08/7/2015 08:500
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Wal (Nostradamus) non avrai mica anche i tempi indicativi per lo 0, 90 :):):);):D
15 di 3906-08/7/2015 15:090
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Wal a che quota conviene roentrare 0, 39??
17 di 3906-08/7/2015 21:060
walberga2
N° messaggi: 5599 -
Iscritto da: 25/9/2010
grafici titoli gratuiti da it.advfn.com
valutare il supp 0.410 se bucato vai a ...min del titolo
18 di 3906-08/7/2015 21:100
walberga2
N° messaggi: 5599 -
Iscritto da: 25/9/2010
e nostradamus non centra niente ,, solo matematica pura comunque vedi oggi era un min non in programma dunque sconfessa tutti i calcoli,, ora si aspetta che trovi il suo bottom di periodo ,,,,,,,,
19 di 3906-08/7/2015 22:480
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
Resto in attesa di sviluppi
20 di 3906-09/7/2015 08:330
enzo76
N° messaggi: 4780 -
Iscritto da: 17/11/2013
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min 0.5600 min max 0.550 ,,,,,