Replies to post #59821 on Biotech Values

[krenjp]

"1) They say the drug extended survival by x, but no mention what the comparison was against, or how they came up with it."


The PR says the drug "extended median survival by 6.7 months or 29 weeks after ALL other treatments were exhausted"

The "All treatments" would be 5-fluorouracil or capecitabine, irinotecan, and oxaliplatin, as well as other combinations of treatment" (Avastin etc)

The PR then says "7 had received four previous lines of treatment before entering the trial."

So it seems the data they announce refers to this sub-group of 7 and not their whole sample, a big NoNoNoNo.

isnt it Dew?

[Kadaicher1]

PRW. The more I read, the better it looks. All patients in the trial had previously been treated with 5FU. Patients have to be taken of 5FU due to toxicity, not because they become refractory. Davanat eliminates toxicity. They saw tumour shrinkage in 43% of patients taking the 5FU/Davanat. Thats pretty good, considering it should be first line.

[DewDiligence]

>PRW – They say the drug extended survival by x, but no mention what the comparison was against, or how they came up with it.<

Indeed! PRW’s use of the word extended borders on fraud, IMO.

What PRW is actually saying in the PR is that patients in the Davanat trial had a median survival of 6.7 months from the date of enrollment, which tells us close to nothing.

Patients who have failed all standard therapies in this disease do not automatically drop dead the next day. For all we know, the patients in PRW’s trial would have lived a median of 6.7 months (or longer) on no therapy at all.

In short, PRW’s PR is not merely a case of hyping the results of a trial without a control arm—it is something much more untoward than that.