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A PR follow up to below is what I expect to up list CYDY off the BB.
http://www.cytodyn.com/media/press-releases/detail/219/cytodyn-files-for-orphan-drug-designation-for-use-of-pro
The Company has selected a transplantation indication called GvHD as its first non-HIV clinical indication. The CCR5 receptor, the target for PRO 140, is an important mediator of GvHD, especially in the organ damage that is the usual cause of death. The only approved CCR5 inhibitor, Maraviroc, is currently in a Phase 2 study in GvHD. The Company believes that PRO 140 has significant advantages over Maraviroc in more favorable dosing and pharmacokinetics, less toxicity and side effects, and no direct stimulation (agonist activity) of the CCR5 receptor.
They are well past 100 days!!
Chump
Paddler- Correct. Someone else here posted the ASM guidelines for PR's.
I cant't find it. But a slew of good news can come out non-related before the ASM.
Chump
salgovernale69- I understood that nothing ASM related can be released until 5-7 days after the presentation which is June 20th. I could be wrong.
Within 2 weeks we could can hear from the FDA on compassionate use and we can hear on Orphan status any day or possibly phase2b results. I share your enthusiasm..in the next 2 weeks or sooner I think the SP will rise and hold.
And a bonus, maybe from Charlie Sheen, if he got into the program. Patient confidentiality will leave that up to him. Going on the OZ show and saying your trying a new treatment is one thing, going back on the show and say your viral loads are lowered, no side effects etc. would grab a lot of attention.
Chump
Looks like Mondays open was a set up to take out stops Tues and today.
Maybe we'll find some higher holds now.
Chump
Ditto!
paddler, I agree. I expect some higher s/p tests. Definitely some buyers out there.
Chump
I believe we have 1 institutional holder +- 30k shares. Thats gonna change soon. Let this get within their reach and were off to the races. Reminds me of Secretariat at the Belmont.The ending is the best.
Yes misiu I agree. My only concern is that the Paulson group or whoever is selling is done before we up list.
Institutions or brokers can't buy Cydy on the bb unless it reaches $5. Otherwise s/p has to be $2 for 5 consecutive days to up list. Or r/s. Those are our options.
Chump
I predict an attempt to break $2 this week. Just a feeling.
Chump
Where's that Orphan Status designation? please! We need over $2 for at least five days to uplist w/o a r/s.
Chump
I copied your "bribery" post and sent it to
https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm
Plead your case to them.
Chump
Shouldn't we expect orphan status approval based on the graph host trials?
or fast tack? Thoughts?
Chump
Shouldn't we expect orphan status approval based on the graph host trials?
Thoughts?
Chump
The True Potential of Pro-140-Functional Cure 1/2
CYDY-Yahoo Board
Alias-carterjkennedy is posting some great info on CYDY's science.
Chump
A very good post from Yahoo Board.
The True Potential of Pro-140-Functional Cure 1/2
In the early days of Hep C (HCV) treatment (Tx), we started with interferon, achieving an 8% Sustained Virological Response (SVR), (SVR=virally negative 6 months after end of treatment) then added Ribaviran, boosted it to low 20's. In 2002 we pegylated the interferon and discovered we could achieve at 40+% SVR. Vertex entered the market, studying Telaprivir, adjunct therepy to the P-INF+RBV backbone. Achieving a 70+% SVR. HCV behaved similarly to HIV in that it hid out in extra vascular compartments much like HIV does. Although HIV is far more insidious. Abbvie and Gilead began studying their respective cocktails, both achieving nearly a 100% SVR in patients that take their medication. So far HAART has done a great job of ridding the body of circulating virus, but nothing to mop up dormant virus. It was once thought that if a patient was on HAART long enough they would be able to be taken off treatment. That's proven not to be the case. In 2007/8 oral entry inhibitors Mariviroc and Vicroviroc were being studied. While Mariviroc was granted marketing approval, Vicroviroc failed to meet its primary endpoints and the program was halted. Mariviroc is basically a DOG that no one uses. It interferes with the other important inflamatory response fuctions CCR5 that PRO140 Does not. I believe very strongly that PRO140, once fully studied and its capabilities born out, will surpass any candidate currently on the market or in development. This Molecule is unique in it mode of action. HIV is not a 1 Billion dollar market, Its a 100 Billion market, once the glabal impact, Prevention (Prep), & Post Exp (PEP) markets are fully exploited. Finally, the ability of PRO140 to be delivered SC with potential of even greater interval dosing (ie once a month, once a quarter? PRO140 could very possibly own this entire market in a very short time. Lets Make sure this Company has all the Capital it needs to succeed. We R Part of something special
Thanks Misiu- Here's the news link
http://www.cytodyn.com/media/press-releases/detail/227/cytodyn-files-a-compassionate-use-protocol-with-fda
Agreed, It's a ride but always invest in the results. CYDY has them as of now.
Chump
So the bottom line is?? regardless of todays 10Q financial's. Clinical results have been positively disruptive in trials and if they continue to be positive CYDY will dilute to progress trials or partnership will want a piece of their science?
Am I correct?
Chump
Closetinvestor, good point I agree. Thanks!
Re-10Q I hoping some more experienced with them can give input as to a positive or a negative. I'm interpreting it as everything is moving forward and positive but since it's a 10Q they have to give the possible negative outcome if the results don't continue as they've been. Am I right or wrong?
Chump
Whew, this is a lot of money. In the conference call Dr. P said finances were in order. Is it the additional authorized shares that can be issued to cover this. Or do they feel FDA approval is near and not a problem. Any input is appreciated.
Chump
PatrickBateman- Very good point, you said, "This sold off on less than 1 million in share volume the past few days. In comparison the move up last week was on 6 million shares. In perspective, about 85% of those buyers are still holding"
Chump
I'm expecting an turn around regardless where the price will be once the vol reaches 250k+.
Just my thoughts.
Chump
XBRIANX- Me either but here is some info to ponder now to June. I consider Asmmicrobe's event to hopefully introduce "disruptive" science in their fields. Here's to CYDY accomplishing this.
First, Here's a link to Authors/Disclosures. (what I was considering peer reviewed)
http://www.abstractsonline.com/pp8/#!/4060/presentation/16215
Second, Everyone else in the room presenting. (GLD very present as JBEM777 pointed out)...I don't see any other competition as mention on other boards from other techs??
http://www.abstractsonline.com/pp8/#!/4060/session/511
With this and additional progress/PR that can come out any time, Ill maintain a hold/long position.
Chump
JBEM777- She's settling...like a 5000lb boulder bout to slip off a cliff.
Come on!
Chump
Inoviorulez- Not to sound flippant. You stated " The big catalysts is the phase 2b HIV data at the conference in June. " I think the invitation alone speaks volumes to the results and presentation to be given. It's been reviewed, they can't discuss it. Asmmicrobe is about successful results and progress in the area of exhibit. I could be wrong.
Chump
Inoviorulez- I'll take all three right now!
Chump
And don't forget CYDY's employee Mr. Caracciolo.
Mr. Caracciolo was formerly employed at Gilead Sciences, Inc. ("Gilead"), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, from 1997 until retiring in October of 2010. During his tenure, Mr. Caracciolo served as Senior Vice President, Manufacturing and Operations and was a senior member of Gilead's executive committee, which was responsible for the strategic and operational direction of Gilead. During Mr. Caracciolo's tenure at Gilead, Gilead grew from 300 employees to approximately 4,000 worldwide, with commercial activities in 38 countries. In addition, Gilead's sales rose from $200 million to over $7 billion. While at Gilead, Mr. Caracciolo had responsibilities of directing operational and strategic imperatives for two manufacturing sites, development of a portfolio of contract manufacturing organizations, producing over fifty percent of Gilead's commercial products, informational technology, compliance assurance associated with aseptic processing, product development, optimization, technology transfers, and supervision of over 600 employees at six global locations.
Chump
Sure wish we could get the green light on orphan status.
tmeier- I agree. Todays trades were unveiling of accumulation. A buy trade at the ask/green for 5k shares at $1.29 then immediately a trade below at $1.26 bid/red for 100 shares. All day. Who the hell sells 100 shares all day? Not retail investors for sure.
JMIO-could be wrong.
Chump
Thank you Misiu. I rely on you physicians for the clarity.
Chump
Do you think this is press worthy? Thanks
Chump
Can someone break this down please!
Chump
Sure wish the vol would pick up. Geez! Too much in CYDY's hopper
to be $1.28,
Chump
Amatuer- I agree but any up date on Charlie will have to come from him not CYDY.
I know you know this already Amatuer.
Charlie can be as good as a road show, thinking of the following he has. Hi Charlie!
Chump
bigstocksnbonds- IMO orphan status, grh/host, and the asmmicrobe published which I feel replaces/negates the need for the BTD results. Unfortunately they can't release it till the event. But having peer review from the asmmicrobe should be priceless. I think CYDY is hitting some major radars not from sp increase or vol etc. but results that are very welcoming for the HIV community and more uses. IMO this isn't a pop and drop but a good value play.
Chump
I read it also but thought it was an easy plug since CYDY had already submitted for Orphan status DEC 21. CYDY BTD submission got me across the line in Jan. And I sweated it till they anncd presenting at the asmmicrobe which is far better. (peer review etc). Now I'm in a holding pattern for results.
Give us results. And as Amatuer pointed out 10 are presenting at the asmmicrobe, 7 are GLD and us CYDY. We should be raising some eyebrows.
Chump
Misiu- Me too! I've heard that delays from the FDA isn't a negative. In short, they give you an up front no when it's no...delays can be a positive. Fingers crossed!!
Chump
tpizzazza24- invested in Feb. Respectfully, I don't follow JBEM or any other herd. I'm in for full value. I've watched CYDY for 5 years. I felt in Feb their progress was significant enough to put my toe in the water. Buy-out? I think theres more meat left on the bone than just for HIV and I'm waiting for confirmation.
G/host etc.
Chump