Biotech Values

[iwfal]

If ONCY had received in Phase III the same results they got from the phase II - fda would approve them....what is so hard to conceptualize?

And

The phase II results were good enough for FDA approval so if they duplicate results they will be approved

1) The ph ii will NOT count as efficacy towards FDA approval - the ph ii results you are referring to were single arm in 31 patients. Not randomized. And not all third line.

2) The 'confirmatory' ph ii they are running in the US is 14 patients (unrandomized, obviously).

3) The results seen in the ph ii you are referring to (42% PR) are absolutely nothing to write home about since they appear to be entirely consistent with the PR expected for treatment with Pac alone in platin resistant head and neck. See here for instance:

http://www.ncbi.nlm.nih.gov/pubmed/19117166

4) Even if, against all indications, the ph iii were stat sig it would be only one trial. Very unlikely to result in approval because the supporting trials are not very supporting.

Altogether I would now tentatively move ONCY into my scam category (and I am a lot more selective than DD when nominating for scam-hood.):

a) A ton of trials that can be predicted in advance to neither confirm nor deny efficacy - and no meaningful trials until 8 years after ph i. This likely requires concious planning

b) They moved to a small ph iii after a ph ii that doesn't actually look good at all. And the ph iii is too small to really say much. This likely requires concious planning.

c) The poster for the ph ii actually makes note of the fact that the PR patients lived statistically longer than the Progressive Disease patients. Well, duh?! (Mentioning of stupid statistics always makes me suspicious.) Not clear whether this was intentional or just idiocy - but either way it is not a promising indicator.