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Ahjay fast track just means the disease is serious and there is...

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    Ahjay fast track just means the disease is serious and there is an unmet need. You and I could develop a drug for ovarian cancer tomorrow and get fast track approval.

    But we wouldn’t get breakthrough designation, accelerated approval or priority review because we don’t have any evidence whatsoever to back up our hopes of a positive effect.

    Picking up on Macenrocs point. In the 10 seconds that it took Macenroc to write his post he provided more analysis than is in the entire analysts report. And that is my gripe about the report.

    On the face of it those results for second remission patients are extremely positive. But they are shunned by
    the market, the FDA, the OC community. And PRR needs lender of last resort funding and has diversified away from Cvac.

    Analysis starts where you begin to answer the “why” to this.

    Maceroc makes a start by saying that it is because the sample size is very small. True but if the baseline characteristics of the two groups were similar so what? Or if the SOC treatment provided to the comparator group was first rate then this advantage to Cvac is even more impressive. If the expected survival in patients with second remission is very low ... just showing improved survival in even one subject is impressive.

    You could also begin to address the concern that everyone has got this wrong. Perhaps the FDA in this area of cancer vaccines is overly cautious and too slow. Or there is a conspiracy with big pharma. Or that how the market assesses drug trial results doesn’t generalise well to this sort of drug approach. Etc etc.

    All these sorts of arguments provide the thing called “analysis”.

    But when noone is any the wiser about any of this after carefully reading the report ... the report has failed.
    The truth is there is more analysis about these trial results on HC than there is the analysts report.

    Contrast this report with ones coming out earlier. For example prior to the Can-3 results an analyst argued that we shouldn’t worry that the interim survival curves from Can-003 hadn’t shown any separation. Because in time those curves would split – and a few semi plausible reasons for that belief were posited. All very debatable - because it was debatable.

    In this report by backtracking to market sizes, how wonderful the whole area it is it just becomes page after page of rah rah. And completely misses the opportunity for making an investment thesis.

    But what was very good to see was Kbear getting 30 odd ticks of approval in response to my polemic. It proves there is life left in the dog yet and positive expectancy in the market about the future. To get a good wack of Ying you do need a bit of Yang.
    Last edited by Southoz: 19/02/15
 
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