Dewdiligence and Iwfal - re ONCY
DAVEAU - "I believe the point was that time to progression could be used as a proxy for overall survival and this is how the registration trial is designed – with an initial look at time to progression (overall survival is the primary end point, not time to progression) in the first 80 patients in order to power the trial."
Dew - "Why would a reputable company think it was necessary to state the obvious? I’m inclined to agree with iwfal on this specific point."
Dew, not sure i understand your reply to Daveau posting. He stated that a private investigator was responsible for the poster on phase II...not the company.
Reputable company ? Having the CEO address the difficulties/issues with advancing a virus thru FDA - doing extensive testing of both healty and sick animal studies, switching manufacturing from animal to human virus, learning about the immune role in administering the virus and efficacy etc for a small company with limited resources - i think the ceo comes across as pretty honest. Some make a big deal out of NCI being involved in 6 trials with reovirus - not sure if i agree with that.
Aside from the randomized studies which has some ethical concerns toward patients and the fact that a small company with a novel product may have a hard time competing for patients with well established and well funded CRO - i think the company has attracted some reputable researchers that are published and involved with reovirus. Last year's ASCO has given a 500k grant to a doctor/researcher involved in reovirus if i recall correctly and there was somewhat of a buzz with his research.
In additiona, the company now that it has treated aprox 450 patients with the reovirus is expanding the clinical trials with randomized studies.
I dont have your nose or iwfal credentials to smell a scam/rat - but i fail to see where you can point to a specific act the company has undertaken - which was not disclosed, discussed or new actions taken (i.e. randomized trials)that would squash those scam rumours.
AI
