Been thinking about it, @ddwn, and I reckon what we are facing is, again, a fundamental lack of sophistication on the part of the Aussie share-buying public, this time vis-a-vis the FDA approval process. This has been one of MSB's biggest problems all along--cutting through to the market to get them to recognise the intrinsic value of this company and its technology. That problem compounded itself today with an opaque foreign approval process that is designed to be very adversarial.
Over on the Yahoo! board, one fellow who had shepherded cases through the FDA was discussing the process, and indicating how boringly common these types of documents were in the process, how it's the FDA's and ODAC's job to scare the living sh*t out of the companies seeking approval, and that you just have to grin and bear it to get through the gauntlet. We aren't the first company to get a glaringly depressing ODAC briefing paper, and we won't be the last.
Once again, though, we LTSHs are too deeply enmeshed in the process. We just saw the price go up yesterday to dizzying heights, and we (well, I) didn't think as hard as we should have about our new "friends" that bought in, and the risk of retracement with such a rapid climb on no news. We should have, though, when that average new buyer has no idea who SI is.
Indeed, the only thing that has "changed" (our being surprised that the ODAC documents were more negative than we expected isn't really a "change," it's more an indication that we were a bit naive, too, about the process) is that we acquired a pool of new fellow shareholders that paid a high price for these shares...but didn't really have the foggiest about what they bought.
They are likely unaware as to what MSB's products are or really do. They don't what the process entails to obtain approval. They are clueless about the YEARS that have gone into research, trials and product development. They have no knowledge of the nearly cheek-and-jowl relationship and cooperation that has existed between MSB and the FDA over the last few years, and most importantly, over the last 6 months (with that stunning list of FDA-involved activities you posted being strong proof of that).
And more than anything, they know nothing of the extreme care and attention to detail that MSB has put into this process to give its first BLA application the best possible chance of being approved by the FDA by focusing on a treatment for a disease in children that is basically a death sentence for them--then being able to use the same drug as a treatment for the global scourge of our time--basically boxing the ODAC and FDA into about as much of a corner as they realistically could.
Anyway, hopefully, the shares today's chumps coughed up are in the now hands of individuals who are at least willing to wait until after the AdComm hearing, seeing as the cost of failure there seems now to have been somewhat factored into the price for which they purchased them.
(20min delay)