Biotech Values

[pcrutch]

ARNA

in reply to wallstarb, I am staying away. I have never supported ARNA and never will. Their results are highly questionable. They were hoping to piggyback Lorquess onto phenteramine after approval, but now, I think it is very unlikely to be approved.

Their results are essentially meaningless and not clinically beneficial. Cancer risk and memory loss? Somehow I think the panel will eat this up more than VVUS. At least all of VVUS risks were very hypothetical with no evidence. The FDA found evidence of cancer risk and memory loss. Not good news.

I don't believe they met the efficacy requirement and the review in the FDA briefing docs agrees they only pass by a "slim margin" on the easiest guidance criteria. They do not even come close to reaching 5% weight loss.

Remember, these FDA docs for weight-loss drugs were just guidance so the FDA will interpret the results however they want. I think hitting the 5% was very necessary for approval. Also the BLOSSOM numbers don't meet the first criterion. 47.5% is not approximately double 25% (it's 1.88).

Being a statistician, I do not trust bio-statisticians/clinical statisticians/ or pharma developers. This is another case in point where ARNA pimped their numbers as significant and guess what, the reviewers at the FDA don't seem to think so.


FDA criteria

"In general, a product can be considered effective for weight management if after 1 year of treatment either of the following occurs:
• The difference in mean weight loss between the active-product and placebo-treated groups is at least 5 percent and the difference is statistically significant

• The proportion of subjects who lose greater than or equal to 5 percent of baseline body weight in the active-product group is at least 35 percent, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant"