Ok solusnauta. if you think approval is coming in 2013, lets wait and see. i advise you ask PRR's management team if thats possible, or probable.when you realise its not, you might want to reconsider your investment case.
you see with your facts:
- many drugs have orphan status, it doens't mean they get early approvals, it just means that the process is faster, i.e when the FDA looks at PIII data and decides upon approval, they may do it in 6-12 months rather than 1-3 years. Also more likely to only require one PIII trial, not more, which is the case for many drugs.
- research says a lot of different things. the fact that one study has come out and said chemo can boost cancer when administered for a 2nd time isn't going to change the way the industry, or the FDA thinks overnight. if there is merit to the study, there will need to be many more studies before it has an impact on approvals/reimbursement/oncologists behaviour. I wouldn't count on it affecting PRR in the next few years.
- your point about CVAC's timing in administration is not going to fast-track its approval.
- your point about pfizers trial is irrelevant.
if the FDA approves CVac after interim data later this year, they will be looking at 1 year data on a small handful of patients. all up its a 60 patient trial, but a fair chunk of that is placebo, so you have very little knowledge and very little statistical significance from this study. They will need to wait for CANVAS results, which at best will come end of 2015 - as guided to by the company.
if you are waiting for an approval in 2013, then keep waiting, and when it doesn't come, sell your shares because by then you may have realised your judgement is way off.
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