"Surely we can be told that there is a focus to get say Vaxinia to the market."I get the frustration, but they have told us they're doing an expansion into biliary tract cancer with 10 patients to be treated once the optimum biological dose (OBD) is established.
It's not really appropriate for the company to say, if from there x happens then we'll do y, but if m happens, we'll do n, however if b happens, we'll do c. Until clinical trials are completed and there's enough data to support the FDA to approve, all they can do is keep running trials. However, it is extremely early days for Vaxinia and they are yet to establish OBD, let alone complete Ph1 so we're not even close to the point where they've having to run trials to find alternate indications Vaxinia could be suitable for. Even the most advanced drug in terms of clinical trial progression, HER-Vaxx, is still yet to complete its first combination trial and despite the protestations by some on here, HER-Vaxx is not yet at that point. It, unfortunately, simply takes a long time to progress the drugs through clinical trials to initially establish safety and subsequently efficacy. Once both of those are established the process will gather pace.
Better questions might be:
Why aren't they enrolling patients quicker?
Why does each cohort take so long to clear until the next one?
Will there be higher doses once the 3x10 to the eighth cohort is cleared?
I don't have answers, but I suspect the answer to the first two questions would revolve around safety and needing to with a certain amount of time to see if any side effects develop. The third question would give insight as to when OBD might be established. If there are to be higher cohorts then it will potentially be many months longer until OBD is established.
I do think some people have extremely unrealistic views on what the timeframes should be. It should be well understood by any biotech investor that deals generally should not be expected until the conclusion of Ph2. IMU is yet to have any product complete Ph2; the closest drug is HER-Vaxx which completed a mono Ph2 and is now getting close to completing a combo Ph2. I'll consider Ph2 for HER-Vaxx complete once the combo is complete, and we'll either see something commercial arise or not.
"I think it's the not knowing and never ending road shows, never ending slide shows, never ending everything that gets the average punter frustrated."Yep, I completely agree. It certainly is very frustrating and while it isn't done, I think if the quarterly reports contained more information to show trial progress it would go some way to alleviating the frustration. i.e. if mining companies can report how much they've dug out of the ground for the quester, surely a biotech can say how many patients in each trial they've enrolled for the quarter. At least we'd have some idea how they're progressing towards obtaining the necessary data.
