Interrim analysis confirmed. Vi har sett skriv på at det skulle skje ved 60 pasienter.
Vi kan få data fra Paradigme veldig snart!
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Bortsett fra at de er forsinket med rekrutteringen: (Paradigme update, Q1 rapport s. 4)
"While good progress has been made opening sites, the company is currently behind where it anticipated it would be at this point in time. The company, working with the Contract Research Organisation (CRO) managing the trial, has implemented several initiatives designed to get site activation back on track and to accelerate recruitment at those sites that are open for enrolment. These initiatives include establishing patient referral networks and also opening additional trial sites. We are closely monitoring the effect of the measures we have initiated to see whether or not the recruitment will accelerate. "
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74 av 80 er bekreftet åpen for rekruttering. Det er heller ikke sagt at alle sites kommer til å rekruttere i løpet av studie forløpet.
Husker ikke i farten om lignende har vært skrevet i en børsmelding? eller er jeg fortsatt i svime i morgentimene?
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Strengt tatt burde jo 74 siter for å få inn 130 pasinter på 2 år være rikelig, så at det mangler at 6 siter er vel ikke krise.
Forøvrig betryggende at de er på ballen, så Nano ikke havner i situasjonen Pcib var i med sitt Extension studie, hvor halvparten av sitene manglet grunnet papirkrøll
Såre enkelt.
At de lufter denne nå likte jeg overhodet ikke, siste vi trenger. De kan ikke ligge bak… 
Kjenner at jeg ikke ble superstresset av dette. Med over 70 siter opp og går, og 12 måneder igjen av guidingen, så bør dette gå fint.
MZL kommer ja - med partner?
Say what?
"Archer-1: “Hopefully data from first six patients by the end of the year - as soon as we have it we will share it”
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Men MZL, sa Bravo at det kommer?
Flott. 6 pasienter kjørt gjennom, og data!
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Jepp! Hadde vært nice med litt Archer-1 snop på ASH, pluss DLBCL, pluss oppdatert mDOR ++++
MZL fra 09:40:
“We are pulling out the Marginal Zone patients with striking data even if it is small patient number. Because there is an increase need for drugs, increased interest from opinion leaders in Marginal Zone. There is very few products that work, so this is an area we are exploring as further devoloping Betalutin into. So stay tuned - you will hear more, most likely, about Marginal Zone Lymphoma in the future.”
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Greit å få med at de to siste MZL pasientene fikk SD også, hvorpå den ene har hatt ‘‘response of duration’’ på 24 mnd ++ og den andre 6 mnd ++
Så ja, man må jo bare være enig med Bravo om at dette er ‘‘striking data’’!
Ikke bare det, MZL utgjør et stort marked, da det er den tredje største undergruppen av NHL.
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23/05-2019 14:25:20: (NANO) Nordic Nanovector ASA - Allocation of PSUs
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God morgen fra DnB
The clock is ticking
Nordic Nanovector has 74 clinical sites open in the PARADIGME trial, still below its targeted 85. However, its development timeline was reiterated: data readout in H1 2020 and first regulatory filing in H2 2020. In Q1 it completed a capital raise of cNOK225m, which the company says will be used to build a commercial-grade manufacturing process. We reiterate our BUY and NOK110 target price.
Q1 operating loss of NOK90m , in line with our estimate of NOK91.5m. Operating cash flow was cNOK-108m, slightly more negative than our estimate. Cash and cash equivalents at end-Q1 were cNOK538.5m. According to the CEO, the company is applying tight cost control while prioritising clinical activities.
Below targeted 85 sites . The company announced on 22 February that it had 69 clinical sites open for patient recruitment in the pivotal phase II trial PARADIGME, and five sites have been opened since then. According to the CEO, it is impossible tell what effect this could have on the trial’s progress, which we agree with as the recruited number of patients matters more than the number of open sites. However, more sites should mean more patients recruited, and the CEO has stressed that it is fully focused on having all 85 sites opened as soon as possible. In our view, it is essential that no further delays occur in the trial as Nordic Nanovector needs to file before competitor Bayer achieves full approval based on its ongoing confirmatory study with copansilib in refractory follicular lymphoma patients. In a scenario where copansilib achieves full regulatory approval in the US before Nordic Nanovector files with copansilib, there is a risk that it would need a phase III trial before regulatory approval can be granted.
cNOK225m raised to establish commercial-grade manufacturing . According to the CEO, one of the most common reasons that drugs are not granted regulatory approval is chemical control or manufacturing; hence establishing a commercial grade manufacturing process prior to launch is essential.
BUY and NOK110 target price reiterated . We continue to base our valuation on a risk-adjusted SOTP valuation, where our likelihood of approval (LOA) for Betalutin is currently set to 50% in 3rd-line follicular lymphoma.
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Dette var nytt for meg!
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Denne er viktig. Ser ut som de har kontroll. 