Agree entirely that “… things have changed”.. as far as I can...

Agree entirely that “… things have changed”.. as far as I can see.

People (especially the non holders who constantly berate things including positive developments) who are in denial tend to hold firmly onto old facts, old premises, and old conclusions.. I wouldn’t believe that success would be within reach if the company were holding onto the past - a lot of newly generated data, such as confirming long term real world evidence, have been in front of the FDA since 8 July and discussed with them since late last year and now re-submitted, with a much more targeted approach aimed at addressing what previously were described as “issues” and whatever are left now to cover off as just “items” of a CMC nature, an approach that does indicate strongly a meeting of minds.

Unless you haven’t really been following things and/or you are in denial, most people will have concluded that things have changed indeed. We should not forget biotechs are high risk investments but if you understand the J curve of private equity, you will also understand the payout for success can be very substantial once the curve turns upward sloping. This is not private equity but the recent progression has not been unlike something moving off the dip in the “J”. Market risks don’t go away, but if you have done a lot of homework to understand what you are investing in, then you should be able see things clearly and perhaps differently..

Just my POV, not advice.. Just really to say I agree that there are clear signals that things have changed.. The company could very well be advancing from a struggling biotech to establishing its first-in-class product that would open up enormous follow-on opportunities..