It's good to remember the roles. The board has an oversight and governance role. Micheal has the Operational and governance role. I am far more cautious to tag operational issues on the board. Sure, the SP has declined a bit but a hold will do that as the cash burns and the critical things are incomplete (albeit sounds like very well underway). The additional time to get the 2 phases on the Healey trial completed was also a kick in the jatz crackers but in the greater scheme of things....... sigh and that is about it. If we see solid results then I expect movement on the commercial front so that will end up being a bit irrelevant in part or full.
I don't see all the clinical hold being on Micheal either. We apparently have the SAB, we do have Berry and I assume that Healey were very well engaged. Healey & Berry should be extremely well versed in the FDA requirements. Without understanding of decision making I can't make a call but I would assume (and a big assumption) that Micheal relied on experts to affirm the submission was compete enough - Berry particularly.
What is straightforward seems to be the clear requirement for animal data, but what is less clear I suspect is "Is that it?" question. I do think the FDA are in a tizzy and that is a shit sandwich for us and everyone else just trying to get things done. When someone throws gravel in the cogs of government, stuff all you can do except keep greasing and hope like hell the crap works its way out and the machine turns just enough (without breaking) to get you a result. I don't think it is as dramatic as all that but having a chat with someone in the know in the FDA is vastly diferent to a formal position. I am sure the company would like the formal position but i suspect they could wait for ever. The FDA have more to worry about than a lil ole drug like ours and an incomplete submission that was bounced. They can just get on with other thngs and refer back to the guidelines and let the company figure it out. So the proactive trials etc are the right thing to do and then Berry and Micheal need to dot all the I's and cross all the T's for a resubmit soon!
Enough of my rambling. Like everyone, I just want to get out of the rut and get the hell on with it. Resubmit and funding clarity. Let's get on with it. All the other positive announcements are nice but likely falling flat until something clarifies the primary pathway to commercialisation.
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15.5¢ Sentiment: Hold Disclosure: Held
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