Biota Bulls are excited over the following statement in Daiichi Sankyo’s 2008 Fiscal results published today.

Phase III clinical trials were completed in Japan for the anti-influenza drug CS-8958. The Company plans to submit an application for regulatory approval during fiscal 2009.

While that statement can be interpreted bullishly an objective analysis of the situation and reliance on known facts is more reliable, albeit not as feverishly exciting. Swine flu, cough cough.

Fist things first, here are the two important announcements by Biota on CS-8958, a long-acting neuraminidase inhibitor, LANI for short.

• November 17
  The double blind, non-inferiority study uses 75 mg of oseltamivir, twice daily for five days as its control.
• March 30 
  Biota also announced that patient enrolment of the key Phase III studies in Asia had now been completed with results expected to be released mid year.

I don’t see any real news in the DS announcement. DS have said the trial is complete, but Biota had already pretty much announced that on March 30. It’s possible I work under too many assumptions, but when the March 30 announcement came out I thought it made it clear that the trial was all but complete. If enrolment is complete and administration is five days then it was all but done, if not already complete. Yes the trial is complete, but then comes the database lock, analysis and interpretation. All DS have actually said is what we knew anyway.

We can interpret DS’s language and intention all we want, but that is conjecture. I also can’t imagine the completion of a trail falls under continuous disclosure. Especially when it was obvious the trial was complete.

Now you have to ask yourself how long does all this clinical malarkey take;  db lock, analysis and interpretation. Good question and as I don’t want you to work too hard, here’s the answer.
The industry standard is moving to electronic data collection. With e-records db lock takes around two weeks, without four to six weeks.
Analysis takes around four weeks and interpretation takes about another four weeks, but some companies announce earlier if they are very confident in the data and analysis.

So from last patient to being in a position to report results takes around 10-14 weeks. Let’s call it three months. Three months from end of March is end of June. The astute reader may have already realised that all my insightful information was a complete waste of time. All they had to do was read the 30 March announcement from Biota; LANI “results expected to be released mid year”.
We may get them earlier and I’m sure DS are rushing as fast as they can, but Biota investors need to hold onto their hats and wait.

Biota

This May 1st presentation on Biota is a great starting place for investors looking to invest in the anti-viral market.

Disclosure: Long Biota.

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