RE: MAP3 Dec 2019 09:35
Hi Canis. Involvement in a previous trial was certainly one of the exclusion criteria of our Phase 3 study. This is normal practice. I don't know whether the managed access programme will count as a previous study, but strongly suspect it will (unfortunately). We will need to recruit 'new' patients. The relations built up with specific centres in our first study could well prove valuable here, as long as they have not 'exhausted' their supply of recruitable patients.
On a more general issue, whilst appreciative of Nolupus' more cautious stance, I disagree with his estimate of the number of patients we need to recruit. The original trial was not underpowered. If we had recruited 200 more patients and they had responded in a similar fashion to the first cohort (and we must assume they would have) then the trial would have still been negative. The power of a larger trial would be to detect a smaller benefit in outcome at a significant level. The subgroup analysis showed significant benefit in a group of less than 200 patients. Measuring outcome in Lupus, whose activity in a particular patient may vary in time with spontaneous remissions ands relapses, is tricky - a fact now accepted by the FDA. I think the new trial will look very closely at inclusion criteria and outcome measures and has an extremely strong chance of returning a positive verdict.
I have a poor record for predicting price movement, but do not share the wildly optimistic immediate forecasts of our visiting rampscallions. So much depends on sentiment and there are imponderables: the time to completion of the trial, the lights need to be kept on, Avion is not exactly GSK, the loss of the US market, the emergence of competing therapies etc I am however increasingly confident that Lupuzor will make it to the market and the Sp will respond. When? Well, I'll be 72 in April. I'm planning with barely restrained excitement to use my investment to fund a fabulous shindig for my 75th .(alternatively, it should cover a modest funeral).