IMUC
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- Depechemode10
- Jr. Member

- Berichten: 75
- Lid geworden op: 25 aug 2010
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Re: IMUC
kunnen we binnenkort een nieuwe ceo verwachten , met mss de nodige koerstijging tot gevolg? 
Re: IMUC
http://seekingalpha.com/article/890661- ... urce=yahoo" onclick="window.open(this.href);return false;
- Depechemode10
- Jr. Member

- Berichten: 75
- Lid geworden op: 25 aug 2010
- Contacteer:
Re: IMUC
Gisteren een koersdaling gehad door nieuwe uitgifte aan 2,10 dollar.
Iemand een idee wat dit concreet betekend ?(hebben ze dringend geld nodig waardoor ze korting geven ?)
Iemand een idee wat dit concreet betekend ?(hebben ze dringend geld nodig waardoor ze korting geven ?)
Re: IMUC
dilution is idd een manier om geld op te halen : op zich niks verrassend voor een kleine biotech. Dé vraag is echter : hoe snel zullen deze extra aandelen opgekocht worden. Bij een snelle respons is dat een goed teken want dan zijn de aandelen gewild en gezocht.
Re: IMUC
Ik dacht dat ze nog cash genoeg hadden om tot midden 2013 door te gaan...
- Depechemode10
- Jr. Member

- Berichten: 75
- Lid geworden op: 25 aug 2010
- Contacteer:
Re: IMUC
Wnr kunnen we resultaten verwachten van een volgende testfase ?
Re: IMUC
Just to set some of the issues raised here in the different postings and responses straight: (1) We have discussed this in previous postings: Enrollment and randomization in this on-going ph II trial are not the same. Randomization to enrollment is about 46% acc. to published numbers from the company. Patients enroll after initial brain surgery (enrollment=informed consent to participate), then they undergo apheresis for the trial and after this they go through the SoC radio-chemo STUPP regimen. Once they have completed that and if they then qualify for participation in line with inclusion and exclusion criteria after the SoC they are randomized 2:1 to ICT-107 or placebo. The attrition between enrollment and randomization is around 54%. (2) We have 21 patients in ph I as published recently at the SITC plus 88 randomized to ICT-107 in the ph II trial, taking us barely accross the 100 patients threshold (44 randomized to placebo).
My take: If this phase II trial is positive already at the pre-planned interim (50% of randomized patients dead) in spring 2013, meaning statistically significant separation of the two arms for median overall survival, IMUC will discuss with FDA and it is highly likely that FDA will accept a filing. Outcome maybe conditional or unconditional approval. If the interim is not yet showing a statistical difference, IMUC will have to carry on till the end. This is projected for fall 2013. If then the two arms separate with statistical significance again IMUC will discuss with FDA and an acceptance of the file is likely (mind you: We have had approvals based on single-arm, i.e. uncontrolled ph II response data for oncology drugs with smaller sample sizes. Here we would have mOS in a randomized, placebo-controlled setting...).
If the phase II is negative, IMUC will dig deep into the evidence to identify sub-populations that benefitted, but for which the trial was not powered or stratified, may be even biomarker based, discuss a phase III protocol specific for this population with FDA and run a phase III under SPA to hit target on this smaller target population - with smaller target market and eventual sales, of course.
My take: If this phase II trial is positive already at the pre-planned interim (50% of randomized patients dead) in spring 2013, meaning statistically significant separation of the two arms for median overall survival, IMUC will discuss with FDA and it is highly likely that FDA will accept a filing. Outcome maybe conditional or unconditional approval. If the interim is not yet showing a statistical difference, IMUC will have to carry on till the end. This is projected for fall 2013. If then the two arms separate with statistical significance again IMUC will discuss with FDA and an acceptance of the file is likely (mind you: We have had approvals based on single-arm, i.e. uncontrolled ph II response data for oncology drugs with smaller sample sizes. Here we would have mOS in a randomized, placebo-controlled setting...).
If the phase II is negative, IMUC will dig deep into the evidence to identify sub-populations that benefitted, but for which the trial was not powered or stratified, may be even biomarker based, discuss a phase III protocol specific for this population with FDA and run a phase III under SPA to hit target on this smaller target population - with smaller target market and eventual sales, of course.
Re: IMUC
http://www.paragonreport.com/IMUC" onclick="window.open(this.href);return false;
Re: IMUC
IMUC wordt vermeld : http://seekingalpha.com/article/1073451 ... urce=yahoo" onclick="window.open(this.href);return false;
Re: IMUC
Insider, enig idee over wat we nog kunnen verwachten ?
Re: IMUC
Evita : zie efffe naar mijn voorgaande posts. Ik denk persoonlijk dat we in 2013 een resultaatgericht jaar tegemoet gaan. Of dat positief of negatief nieuws gaat zijn ... weet ik niet maar mijn aanvoelen is dat het snor zit. De resultaten zijn nog altijd goed dus.... 
Re: IMUC
http://finance.yahoo.com/mbview/threadv ... la%2Cd%2C0" onclick="window.open(this.href);return false;
het ziet er GOED uit !
het ziet er GOED uit !
Re: IMUC
ik vermoed dat er "iets" op til is want de markten staan in het rood maar IMUC volgt absoluut die trend niet ...
http://finance.yahoo.com/mbview/threadv ... la%2Cd%2C0" onclick="window.open(this.href);return false;
http://finance.yahoo.com/mbview/threadv ... la%2Cd%2C0" onclick="window.open(this.href);return false;
- Depechemode10
- Jr. Member

- Berichten: 75
- Lid geworden op: 25 aug 2010
- Contacteer:
Re: IMUC
Vanwaar de plotse stijging ?
Re: IMUC
kun je nagaan .... ze moeten de publicatie van de interim resultaten uitstellen .... omdat er niet genoeg "events" zijn gebeurd (lees : er zijn niet genoeg patiënten overleden tijdens de referentieperiode) !!! maw ICT-107 werkt zeer goed !
http://finance.yahoo.com/mbview/threadv ... Cd%2C0%2C3" onclick="window.open(this.href);return false;
http://finance.yahoo.com/mbview/threadv ... Cd%2C0%2C3" onclick="window.open(this.href);return false;

