trial

Thought it might be an opportune time to speculate on what Avexa is looking for in these Phase 3 trials. Its not a question of 'does it reduce viral load'. That's already known and more of that result won't mean anything. It would obviously be a prob if it didn't happen of course, but logically, there are more than 150 patients past the 16 (and prob further) stage of the trial and there's no indication of anyone being pulled out of it.

Remember that this trial is simply ATC in 2 doses versus 3tc (ie no 'untreated' controls) and an independent review committee is getting access to the results as the trial goes along. You'd think that if any group of patients on the trial was being severely disadvantaged (eg having high viral loads), patients would be withdrawn by their doctors or the trial might be stopped (and that that would presumably be announced to the market). That sort of event would be (I assume) reported to the market. The fact there haven't been any probs reported has to be a positive indication of progress in the trial.

(this (above and below) is my own interpretation - do your own research and come to your own conclusions)

The big issue is whether the dose at 800mg works as well as the higher dose being tested (1200mg). That's very important because the 800mg dose will be a good fit for the standard fixed dose combinations of drugs now being used, where the higher dose won't be as easy to use. and may (additionally) trigger more trials to see if even more ATC is better again. If 800mg works as effectively (or close enough to it) as the higher dose, Avexa can then say the dose is established, the dose will be suitable for standard fix dosage regimens, big pharma know exactly what they are dealing with and are hence more likely to enter a partnership agreement.

The way i see it (again, circumstantial) , there was little between the effectiveness of 600mg and 800mg doses in the earlier trial. Plus, those results were already very good, meaning there isn't much scope for 1200mg to be greatly superior to 800.

To me, everything points to this trial (phase 3) providing...

1. significant benefits to patients by reducing viral load, (because phase 2 showed that already and people prob would have been pulled out of this phase 3 trial had there been problems).

2. support for 800mg being the defined dose (based on the earlier results showing little effect of jumping from 600 to 800).

If those things happen, the trial then expands to include a lot more patients at the single dose (hopefully 800mg) to confirm the improvement compared to 3TC. That WILL need a partner with deep pockets. Hopefully those prospective partners are waiting to pull the trigger once 16week data takes a lot of the risk away.

This post has been my own interpretation of things - do your own research and come to your own conclusions.