altolivello
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aisssssssssaaaaaaaaaa
AIS - Antares Pharma, Inc. (AMEX:AIS)
- Creatore Discussione osinod2
- Data di inizio
cervellofine
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- 30/10/06
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.
1,86 Clau
vicini ad un break di lungo periodo, dopo più di un tentativo o di un suo accenno che dir si voglia, i num ci sono tutti, forse anche le liete notizie..partnership Biosante e Teva, watch
1,86 Clau
vicini ad un break di lungo periodo, dopo più di un tentativo o di un suo accenno che dir si voglia, i num ci sono tutti, forse anche le liete notizie..partnership Biosante e Teva, watch
cervellofine
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Quotes for AIS - Yahoo! Finance
Antares Pharma initiated with an Outperform at Oppenheimer
Companies:
Antares Pharma Inc.
.
On Monday May 23, 2011, 5:33 pm EDT
Target $3.20.
Antares Pharma initiated with an Outperform at Oppenheimer
Companies:
Antares Pharma Inc.
.
On Monday May 23, 2011, 5:33 pm EDT
Target $3.20.
the volture
OLL LLIINNN 📢📢
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cervellofine la stai seguendo??
2$ è lo spartiacque
2$ è lo spartiacque
the volture
OLL LLIINNN 📢📢
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rw 1392 per favore puoi postare una tua view...sarei interessato a vedere i tuoi livelli di resistenze sopra la eventuale rottura di 2$...
the volture
OLL LLIINNN 📢📢
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Sparti/acquee
cervellofine
Volare libero
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ciao, un target conservativo è 3,20 se vuoi una view personale, nn in 2 giorni
RW1392
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Muro dinamico ascendente nero a $ 2.04
Ottima una chiusura/apertura superiore.
the volture
OLL LLIINNN 📢📢
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doppio massimo a 2,65 di medio periodo,,,un long ci sta,,,,,,
namooo
namooo
Mallella
So di non sapere
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doppio massimo a 2,65 di medio periodo,,,un long ci sta,,,,,,
namooo
BPAX dovrebbe seguirla a ruota...
the volture
OLL LLIINNN 📢📢
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Chiusura a 2.69......nuovi max angli ultimi 3 anni....vediamo domani....
Rw 1932,se riesci,dammi un tuo dipinto....grazie
Rw 1932,se riesci,dammi un tuo dipinto....grazie
the volture
OLL LLIINNN 📢📢
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abbandonato la nave..ais mi è sempre stata sul .......
indurain
Alles Door Oefening
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Antares Pharma, Inc. (ATRS) today announced positive results from a human factors usability study for VIBEX Methotrexate (MTX), a proprietary auto injector product designed to self-administer a rapid subcutaneous weekly injection of methotrexate for the treatment of rheumatoid arthritis (RA).
The purpose of this study was to conduct a cumulative and summative round of simulated usability testing of the VIBEX MTX device in accordance with Food and Drug Administration (FDA) draft guidance “Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated June 22, 2011”. The study design was reviewed by the FDA prior to initiation. Fifty individuals representing three user groups participated in this study, including 17 RA patients, 16 lay caregivers and 17 healthcare professionals. All participants in the patient group had been diagnosed with rheumatoid arthritis by a physician. In addition, the patients were screened twice using the Health Assessment 20 Item Disability Scale (HAQ) to determine the extent of hand function impairment of the sort associated with RA patients. Patients with an average HAQ score of 2.0 to 2.5, defined as “severe to very severe” hand function impairment, were enrolled into the study.
The RA patients and lay caregivers (n=33) completed simulated injections on two days spaced one week apart, which is reflective of the intended weekly dosing. The healthcare professionals (n=17) participated in a single session where they used the device on a simulated patient. The results of the study showed that the VIBEX MTX device is safe and effective for intended users, uses and use environments. The validation testing proved the product is easy to learn and safe to use as demonstrated by correct and successful injections.
The Company is continuing to conduct additional studies including an ongoing human use study in 100 RA patients, and expects to complete enrolment in this study during the third quarter of 2012. Antares Pharma continues to expect and remains on track for a first quarter 2013 NDA filing of VIBEX MTX for self-injection by patients with rheumatoid arthritis.
“We are very encouraged by the results of the usability study, particularly in the rheumatoid arthritis patient group where the intended users of our VIBEX MTX device will have moderate to severe hand function impairment,” said Kaushik J. Dave R.Ph., Ph.D., and Executive Vice President Product Development. “We are looking forward to completing the next development milestone of our VIBEX MTX product in 2012 which is a human use study in rheumatoid arthritis patients.”
The purpose of this study was to conduct a cumulative and summative round of simulated usability testing of the VIBEX MTX device in accordance with Food and Drug Administration (FDA) draft guidance “Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated June 22, 2011”. The study design was reviewed by the FDA prior to initiation. Fifty individuals representing three user groups participated in this study, including 17 RA patients, 16 lay caregivers and 17 healthcare professionals. All participants in the patient group had been diagnosed with rheumatoid arthritis by a physician. In addition, the patients were screened twice using the Health Assessment 20 Item Disability Scale (HAQ) to determine the extent of hand function impairment of the sort associated with RA patients. Patients with an average HAQ score of 2.0 to 2.5, defined as “severe to very severe” hand function impairment, were enrolled into the study.
The RA patients and lay caregivers (n=33) completed simulated injections on two days spaced one week apart, which is reflective of the intended weekly dosing. The healthcare professionals (n=17) participated in a single session where they used the device on a simulated patient. The results of the study showed that the VIBEX MTX device is safe and effective for intended users, uses and use environments. The validation testing proved the product is easy to learn and safe to use as demonstrated by correct and successful injections.
The Company is continuing to conduct additional studies including an ongoing human use study in 100 RA patients, and expects to complete enrolment in this study during the third quarter of 2012. Antares Pharma continues to expect and remains on track for a first quarter 2013 NDA filing of VIBEX MTX for self-injection by patients with rheumatoid arthritis.
“We are very encouraged by the results of the usability study, particularly in the rheumatoid arthritis patient group where the intended users of our VIBEX MTX device will have moderate to severe hand function impairment,” said Kaushik J. Dave R.Ph., Ph.D., and Executive Vice President Product Development. “We are looking forward to completing the next development milestone of our VIBEX MTX product in 2012 which is a human use study in rheumatoid arthritis patients.”
indurain
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