Flu-iiQ and you

It's interesting that symptom relief has been at the centre of many influenza trials. Because for many other drugs, it isn't. Influenza seems to have been selected out for special attention in this regard: whether it's the company's own marketing departments who want it, or whether the FDA directs it, I don't know.

For most other infectious diseases, hard outcomes are usually preferred. If I wanted to trial a new antibiotic to treat pneumonia, I'd look at fever, pulse , BP, respiratory rate, changes in blood counts, days in hospital, days off work and serious morbidity and mortality. We aren't usually that interested in whether the cough is still troublesome, or your muscles still hurt a bit or whether your appetite has returned or not. Those are subjective and less helpful in determining effectiveness.

If I was to apply hard outcomes to influenza trials they might be:
time till fever resolves
time to pulse, BP improves
time till bloods improve
(perhaps) days off work (although this is also subjective in many ways)
complication rates, including hospitalisation
mortality

Here is the paper introducing the Flu-iiQ test. It was published in May 2011 and sponsored by MSD. The paper, with its validation, was published just before the LANI trials started.

http://www.valueinhealthjournal.com/article/S1098-3015%2811%2900107-0/fulltext

It would be interesting to know where else this instrument has been used - because I can find only 1 reference in Pub Med to a paper looking at patient reported symptoms in Hep C.

By using soft data, like patient reported outcomes, rather than hard data, like objective clinical measurements, you are subject to the validity of the instrument.

It looks like Flu-iiQ is so new that it has not been used in significant studies. Before Biota's. Let me know if I'm incorrect.

Also, given other NIs trials didn't use it, it's hard to make comparisons between them.

Did Biota scientists select it? Did Barda? Why use it? This is the small stuff that needs sweat.

Well, it needs sweat before it's implemented. Too late now.

It's ironic that in his previous job Russell Plumb sold a compound for a lot of money that subsequently failed, and in this job he was handed a compound that failed and cost his company a lot of money.

It's hard to see a way forward. BOTA is a cashbox now, but 80 million buys very little in this still overvalued biotech market. And in any event, they didn't want to wade back into early stage compounds, which is really all they can afford. They can't fund a phase 3, and could only manage a straightforward Phase 2 depending on the patient population. But on the other hand, this company changes major strategy every 2 years, so nothing decided last year is worth anything.

In my experience managements with this much cash hold on tight. It's a decade of salaries. It's hard to know how these directors will handle shareholder pressure, but remember a big proportion are still you and me and we are invisible to them. It's so reminescent of NABI that it's almost eerie. I was kidding a few posts back about being the subject of a backdoor listing, but it's as likely as any other outcome right now.

Vapendavir and RSV are poor reasons at best for them to continue as a stand alone company. The new management team looked very unfavourably on VAP initially. The change of heart comes from having no plan B, or maybe someone in pharma told them they were interested. But neither have strong cases at present. VAP outcomes are all about symptoms in a subset of common colds, although asthma does come with some hard outcomes.

I guess it does offer something in addition to the cash that might let them give back what the funds paid in the capital raising in January.

Generic relenza? Not if the generic needs to be supplied in a rotahaler.Waste of time.

LANI is Daiichi's drug. But they never showed the slightest interest in ROW deals (or at least, none that Biota ever disclosed), so it's unclear they would bother or care now, except that government pressure may be brought to bear in Japan to account for this trial result.

Boy, what a mess.

Problem is there isn't a lot of faith in the large number of Directors gathered at the table. Management does have time and some money, but not enough of either to waste.