Dog days

Biota's share price continues to fall, surpassing the recent drops in Nasdaq overall Biotech Index. Certainly overnight the Index recoverd, while BOTA continued to slip.

There has been no information released since the ROTH conference a month ago.

I guess there are concerns or expectations (or maybe knowledge) that the LANI Phase 2 trial will need to be extended. That would be a bad outcome and that would be reflected in some further  shareprice pressure, and more importantly no real momentum for some time.

At this point though, a positive outcome (acceptance of current Phase 2 results and moving to Phase 3 this year) would certainly improve prospects.

Also, as I've mentioned, no news of a deal with Daiichi Sankyo will also suppress the share price. This outcome isn't reliant on the weather or the science, just the management. It needs to be done to give the market clarity and confidence.

DS should be in a better mood since they have partly cut themselves loose from the millstone that was Ranbaxy.

The BMJ and Cochrane continue their ongoing ideological battle with Roche over Tamiflu. It's relevant in that it drags Relenza and other NIs into the crossfire. As best I can determine, the release of all of Roche's clinical trial data didn't actually change very much about the conclusions reached in the published data.

The problem is that the trials were not powered to demonstrate anything other than effectiveness in reducing the severity and duration of seasonal influenza. That was the target market at the time. To conduct a trial to examine mortality or influenza complications like pneumonia is a very different beast. A much bigger beast.

For the BMJ and the reviewers to argue that the trials should have been conducted independently (i.e by them?) is to make a statement about all drug trials. They do concede they are making statements about the whole system of trials and registration, but they really hate Roche. To criticise the trials as placebo trials is really getting a bit petty. There is no real alternative treatment for influenza.

Whatever they might think of the treatment effect of NIs in regular use, the Cochrane investigators are wrong to extrapolate that NIs are therefore of no value in an epidemic or pandemic. The CDC, WHO and I, think that they are. Other studies, the basic science behind NIs and post-surveillance clinical evidence supports "our" (you know me and my buddies at WHO and CDC) view. In Australia, I recall an interesting statistic during the last H1N1 outbreak: none of the people admitted to ICUs (including those who subsequently died) with influenza had received prophylactic or treatment NI prior to admission. The effectiveness of intravenous NI was established anecdotally during that outbreak, but more formal evidence of the impact of the IV form could assist in assessing the impact of NI in desperate situations more quickly than population studies. NIs will save many lives in the event of a pandemic; the notion that a vaccine will be developed in a few short months presumes that everything functions pretty much as normal for those months in a real pandemic. My guess is that it won't, and the stockpiled NIs will be the first and second line of defence.

There is a strong British anti-pharma anti-corporate bias in all this work. Indeed there is a strong British anti-treatment bias that pervades a lot of Cochrane. But they really hate Roche, and are convinced they deceived the MOH and the people. The fact that the Cochrane Tamiflu reviewers could not be ever seen to be independent themselves is a flaw in the process. They are activists, which I support and applaud, but maybe someone else should do the work.The meta-analysis process is not above interpretation or bias. Activism for evidence is wonderful as long as the community doesn't actually suffer from a lack of common sense in the absence of exhaustive evidence.

The touchy subject of the effectiveness and efficiency of influenza vaccination has always been left undiscussed. Influenza vaccine is gathered along under the voluminous skirt of vaccination support. But is it reasonable that a vaccine that changes every year and needs to be administered to the whole population every year with no guarantee about the targets and no trialling for each new formulation could be at least pondered without being seen to be anti-vaccination? I don't know why GSK escapes the ire of the anti-corporates just because it makes influenza vaccine. That's why I always thought a universal treatment for influenza was a great step forward. It's ironic that a universal vaccine would be hailed, whereas a universal treatment/cure is heavily criticised.

Of interest, many of the Relenza trials at least here in Australia were conducted by Prof Chris Silagy, one of the earliest and strongest advocates for Cochrane and evidence based medicine.