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Grip it and Sip It

03/09/17 8:37 PM

#11991 RE: trding #11989

I was reading the guidelines again today and it says "within 60 days" for decision, leaving little ambiguity.

However, there was a caveat (that escapes me) that could extend to 75 days and I think it may have to do with concurrent studies.

In reading the FDA info, they make no bones about assisting companies and go as far as saying they recommend and assist companies throughout the process. It's possible we could go into another two weeks and that could be positive if they grant approval for adjunct or ODD. Also, in reading it, it looks like the company needs to show it has the ability to manufacture the drug if approved. That may be the reason for the agreement last month. This looks like Cariociolla getting his ducks in a row for a 1-2 punch!!

This is akin to taking your road test. Lots of people fail the first time however the driving instructor tells you what to work on and I suspect there's about a 99% pass rate second time around. CYDY was NOT submitting that application without supreme confidence. They gave Cariociolla over 1M shares to lead the company within a month of the decision?! C'mon! It's in the bag!

Now, even I feel better after seeing this in print. I think everyone should set an "alert" price and don't look at the computer tomorrow! Figure out what your price is and go from there. I want to know when it hits $1.50. Then I have choices to make.

Pigs get fat- hogs get slaughtered. If I can ride this pony to $2.50-3, I'm good with that! Y'all staying long will have the biggest cheerleader in me hoping it goes to $10!

Grip
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Saltz

03/09/17 10:05 PM

#11994 RE: trding #11989

Trding, I follow your logic. We are speculating so nothing is for sure. Fingers crossed...this is important for many reasons. Not a deal breaker as I have said but certainly a longer path.
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newmike

03/13/17 10:07 AM

#12162 RE: trding #11989

Thanks, trding,



Therefore, CytoDyn needs data from that specific population that the Breakthrough Designation was applied for in order to be granted that Breakthrough Designation.

CROI confirmed just that, go back and listen to the conference.

I think we are off to the races. YES