NUZ -- New Investor thread, page-1752

Given the current conversation on this thread, I want to reiterate theconcerns I raised earlier, which I believe are now even more relevant.

When the FDA placed the IND application on clinical hold, the company immediately commenced additional trials — before receiving formal written feedback from the FDA. That timing raises a valid question:

Did thecompany already know what the FDA’s objections would be?

We were told the FDA would provide a detailed explanation within 30 days. It’s now been nearly six months, and shareholders have still seen no such “detailed explanation.” Yet the company, of its own volition, went ahead with an animal trial — apparently based on an assumption of what the FDA might require.

This inconsistency adds further weight to my concern that the company may have already been advised — and possibly ignored —specific requirements prior to submission.

So again:

· Why weren’t those issues addressed initially?

· Was this a strategic misjudgment, or was key preclinical data simply overlooked?

Either way, the result is the same: delays, addedcost, and greater uncertainty.

I stand by my previous position — that we’re only beingtold what the company wants to disclose. That’s not transparency — that’s damage control. If the initial IND was lodged without addressing known concerns, then shareholders deserve to know whether this was incompetence ora calculated risk gone wrong.