US Stem Cell Inc (USRM)

[Dragon Lady]

That's all fine and dandy- I guess I'm not getting or missing this point of splitting hairs between the "biologics" dept. and the word "drug"?? Cause if one follows the links in the very email to the "approval process" - it leads right to a "new drug" application process as far as I can tell?

Further, the CELTEX warning letter, under the long arm of what I guess is the "biologics" dept., leads right to them labeling the company as trying to peddle/sell a "drug" and what the implications are behind that.

So, I guess I'm confused. My understanding, is your point is that flying under the banner of the "biologics" department will someone make a phase III for lack of a better word "easier" and also make the product approval process "easier" somehow and thus somehow cost less? That's where I guess the connection falls apart for me- as I'm just not seeing that part of the argument?

Again, the key link in that entire FDA response email to me- is that CELTEX warning letter and all that it states and implies- and it all leads to, IMO, the essence that they need to treat their product as a "drug" (via the biologics dept or whatever) and regulate it as a "drug" and get it properly approved as a "drug"- all via the "biologics" arm of the FDA? So how did that get CELTEX "off the hook" or on to some "easy street" road to an approval or whatever?

That's where I'm at? It all just leads back IMO, to a good ole "FDA APPROVAL" (phase I, II, III, approval submission, new "drug" application from those links it appears) which is costly, takes enormous amounts of time and paperwork and money- right back to where the trials are at right now, as far as I can tell? Is there something different in the story?