Just my take but I know a lot of people who will not invest in biotech/start up pharma exactly because of the unweildy timelines and potential for unwelcome surprises.

My guess is that Don is genuinely excited when he says he is. Also that because of his relatively limited drug development experience prior to this one, it may be hard for him to realize/accept/account for/feel like he can justify the timelines of the regualatory review process to his shareholders. So then he shoots himself in the foot when he overpromises.And when he cuts trial timelines short to please investors.

So yes, it "could" have generated data as early as May ... IF their submittals had been almost instantly approved (which almost never happens in government, even when they are moving fast), and IF enrollment happened almost instantly, and if everything he imagined went as smooth as clockwork AND IF the results were so patently clear that analysis was almost unnecessary.  Could.   IF.   That was always too many ifs to make it worth saying that. Like the hare that is so sure he will win that he trips himself up.

His optimism takes over and he gets ahead of himself. Same with the patients walking out of the hospital in 2 days comment. Even if he has reason to believe that "could" happen, it is patently foolish to state that it is expected when investors will now be angry if it doesn't happen. 

Instead, there should be careful trial design with prespecified analyses by other preexisting conditions, biomarkers, severity of disease, age, and other relevant factors. Included in that should have been a longer subtrial set up to examine long haul effects, where we would have been most likely to shine.

Someone probably will have data within 4 weeks of full enrollment. But that may not happen right away. And there is usually some time lag in verifying and getting results from researchers to company. And then they need to analyze it (again). And God forbid we fail primary endpoints again despite showing promise in some subset of pre-specified or non pre-specified patients or conditions.

Other companies that may be  fleeter of foot could still beat us to the punch. He knows that (But rushing studies is NOT what makes them fleeter of foot.)

Combined with investor impatience, anxiety to demonstrate results, and what at least seems to be genuine enthusiasm and promise.. it seems like he just keeps making the same mistake. 

He needs to consult those on his team who can caution him about timelines and excessively optimistic statements. Promise less. Deliver more.

To me these two presentations came a little too close to that penny stock pump and dump vibe. I respectfully disagree with almost everybody here in that I think we need not to rush marketing or even trials -  but to take the time to design them very carefully so that they have every chance to succeed. Under promise, over deliver, and run from any statements that reek of pump and dump or despair. It takes as long as it takes, but for God's sake (and that of humanity), just get it right this time. No matter how long it takes.

I would rather see unimpeachable science with stellar analysis and results  than a million such interviews. 

And while it would be great if the science could be expeditious too, given the choice i would rather it took 6 months or even three years longer to get to a win, vs. less tiime to yet another failure.. i would always choose the longer timeline over the utter waste.

Not sure about others, but i think most people dont buy into a highly speculative start up biotech penny stock expecting major gains in the short term. These are long haul investments almost by definition unless and sometimes even with successful trials already in the bag. That's why it makes no sense to put too high a percent of one's funds into something like this so early on, but makes sense to put a comfortable amount and keep other money free for more active trade.

At least that's what i think. Not a cheerleader for Don, just a little non-plussed at the degree of criticism. I agree that he needs to improve his rap. And it is improving but not there yet. And i agree that he is not the right speaker for certain audiences. But no matter how slick someone may be, regulatory timelines are what they are unless (maybe) you are from a big company that weilds both cash and deep influence.

Waiting sucks. But much of the timeline is not Don's fault EXCEPT MAYBE for rushing into studies, underpowering and selecting endpoints and anticipating results that were too ambitious. And maybe even not that, because studies are actually meant to be for learning. And they have learned a lot about this compound and technology. Just look at how the explanation of it has evolved over the years.

Regardless, the one and only thing that will really sell this is a successful trial. No marketing, partnering or anything else can replace that. So that is where the most imoirtant effort should be.

I was actually furious that there was no study component planned to address long-haul effects. 

OK, End rant. At least for tonight.