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Very nice post Blane. Puts the global perspective in place. I expect the World Health Org to jump on this very soon. Continued results for the FDA and a little partnership will launch this.
Chump
Thanks Blane..very rock bottom and undervalued. Next few weeks should reveal a more realistic daily trading s/p.
Chump
Me to 5Top- but I think the OTC board trading has a closed door to anything more than we can speculate on. Wait em out 5Top wait em out. I think a lot will happen with the S/P till we up list organically or not. Once we do, smooth sailing. Sam Cooke, it's been a long day coming but I know a change is gonna come. Book mark it. We have the upper hand/results. Let it play out. I apologize if I sound like I'm talking down to you. You've shown plenty of DD. Just wait.
Chump
It feels like tomorrow could be an up day. Just a feeling.
For longs of course, shorts....I'd could be a bad day if news breaks! For those waiting on .60-.70 sp. Any day!!!!!
Chump
Misiu- I agree. CYDY could be talking to big Pharma as we post now. My point is why would you think CYDY and big Pharma would be an option? The answer is why you invested. The results and progress points to an eventual sit down with some big Pharma. Same reason I invested and comfortable with CYDY regardless of today's S/P. CYDY hasn't had they're run yet. I'm also much more patient now at my age than in my 30's. lol
BTW- Don't forget SeeThruEquity price target $3.40. Somethings cooking.
Chump
Thanks Misiu- I've posted this already and posting it again because I believe it's around the corner. As of July 21st.
CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140 of Treatment-Naïve HIV Patients
60-PATIENT TWO-WEEK STUDY ALSO CARRIES POSSIBILITIES OF BREAKTHROUGH THERAPY DESIGNATION
VANCOUVER, Washington, July 21, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen. The generation of these assay results typically takes approximately two weeks
The basis for CytoDyn’s request is stated below in an edited excerpt from the Company’s recent letter to the FDA:
The estimated incidence of new HIV infections in the U.S. is just under 50,000 per year, an estimated 47,129, 49,273 and 44,073 people were diagnosed with HIV infection in the U.S. in [2013, 2014 and 2015, respectively] (Centers for Disease Control and Prevention (CDC), 2016). CCR5-tropic strains are found in about 90% of treatment-naïve patients (Hoffmann, 2007; Brumme et al., 2005; Moyle et al., 2005; Mueller et al., 2007). PRO 140 is a unique product dissimilar from currently available treatments for HIV-1 Infection. Unlike HAART, PRO140 treatment can be initiated immediately after HIV diagnosis, while waiting for genotypic drug resistance assay results to construct an optimal antiviral regimen. Therefore, we would like to request orphan drug designation of PRO 140 for HIV-1 infection in treatment-naïve adults while waiting for drug resistance assay results to construct HAART regimen.
On July 18, CytoDyn submitted a protocol to the FDA for a Phase 2b clinical trial with PRO 140 for treatment-naïve HIV adults and the Company expects to file for a breakthrough therapy designation upon receipt of successful results for the first few patients. The Company believes that should the treatment-naïve trial be successful, it may position PRO 140 for a much faster path to approval compared with the Company’s two other Phase 3 trials with PRO 140.
5Top- My experience is to not try and figure out why it's trading in this range (which I agree is "different" than previous months) but staying focused on why I bought in, the science and "end-data" results. It's the OTC, shell game being played. CYDY hasn't been in any position in the past financings to really get more than just enough to stay in biz. With the recent progress and results the financing options will now be in CYDY's favor. More competitive etc. If new financing is disclosed I believe we will see that it is more advantageous to CYDY and it's shareholders. Dilution just as a R/S can be done in a positive way when the companies ducks are in a row. The Director buying in is a huge indicator he's comfortable with SP fluctuation because he's looking down the road. I think we're but a few weeks of more supportive news. So what if you bought in at .80 or 1.20 if it goes to 4 or 5?
Chump
5top,Bucky- Yes, IPO's can be uneventful. Due diligence is required the same as with investing in CYDY. My point was if you due your DD and invest before one goes public you have a superior investment advantage decision. Call and ask for a NDA and your an automatic insider. Invest PRE-IPO or don't afterwards. Another example https://www.palantir.com
Same folks that started Pay pal. Follow the innovators, technology.
I was just pointing out to Goldenisla there are many ways to invest.
IMO-I think CYDY's SP is almost at a private offering level. .10-.20 swings will be irrelevant soon. It's an early bird offering.
Chump
Gildeisla- if your looking for a slam dunk maybe keep your eye on this company going public next year.
http://lightfleet.com/about-lightfleet/
Say good bye to switches.
Just a tip. I'm going dancing now. Salsa alive!
Chump
'Company expects to file for a breakthrough therapy designation upon receipt of successful results for the first few patients. The Company believes that should the treatment-naïve trial be successful, it may position PRO 140 for a much faster path to approval compared with the Company’s two other Phase 3 trials with PRO 140'
Amatuer, Goldenisla- With the clock starting at July 21, any time they could get a response. But there's a big play ground to invest in. Timing is most crucial. CYDY is my sand box for now.
Chump
CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140 of Treatment-Naïve HIV Patients
60-PATIENT TWO-WEEK STUDY ALSO CARRIES POSSIBILITIES OF BREAKTHROUGH THERAPY DESIGNATION
VANCOUVER, Washington, July 21, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen. The generation of these assay results typically takes approximately two weeks.
The basis for CytoDyn’s request is stated below in an edited excerpt from the Company’s recent letter to the FDA:
The estimated incidence of new HIV infections in the U.S. is just under 50,000 per year, an estimated 47,129, 49,273 and 44,073 people were diagnosed with HIV infection in the U.S. in [2013, 2014 and 2015, respectively] (Centers for Disease Control and Prevention (CDC), 2016). CCR5-tropic strains are found in about 90% of treatment-naïve patients (Hoffmann, 2007; Brumme et al., 2005; Moyle et al., 2005; Mueller et al., 2007). PRO 140 is a unique product dissimilar from currently available treatments for HIV-1 Infection. Unlike HAART, PRO140 treatment can be initiated immediately after HIV diagnosis, while waiting for genotypic drug resistance assay results to construct an optimal antiviral regimen. Therefore, we would like to request orphan drug designation of PRO 140 for HIV-1 infection in treatment-naïve adults while waiting for drug resistance assay results to construct HAART regimen.
On July 18, CytoDyn submitted a protocol to the FDA for a Phase 2b clinical trial with PRO 140 for treatment-naïve HIV adults and the Company expects to file for a breakthrough therapy designation upon receipt of successful results for the first few patients. The Company believes that should the treatment-naïve trial be successful, it may position PRO 140 for a much faster path to approval compared with the Company’s two other Phase 3 trials with PRO 140.
Amatuer17- Maybe but what if Orphan Status is granted and they say they will raise capital for manufacturing/licensing etc?
Then that .90 becomes 9.00.
Chump
Inoviulez, Please post the short update tomorrow. I think some wise shorts are getting out feeding to some newbie shorts to get in. With the potential of partnership/ FDA Orphan status etc. Being short here is like playing in a minefield.
Let's hope for an up vol Friday unlike the last few.
Chump
5Top- I'm no expert. IMO you're right the bid at 76k is from 5 fifferent MMID's. Unfortunately on the OTC they are just dealing between themselves. On a Nat'l exchange this view would be huge. But I do agree, news and all the greedy ones will on the bid side hoping to later sell to the Nat'l exchange MM's. CYDY just has to keep the good data, like today coming out.
CYDY's board is just as aware as us the need to up list. My tea leaves say if they don't by August 26 deadline is because they have a nice Ace in the hole and know it will be enough for up list. More important for organic up listing than R/S, shorts would try and kill us. Hold the faith!
Chump
5Top- you are correct. I took it as this will allow/approve pro 140 for 2 weeks to keep viral loads at best until a regime is established with or with haart. Money from a partner, licensing. We'll have to see. It just brings in revenue.
All of this i know you know justs speaking to the board.
Chump
Upon approval licensing and moving towards revenue will be huge.
Got to hand it to them what they've accomplished with the FDA would take most companies many many years. It's the results that are capturing their attention.
Chump
5Top- You're all good with me. Thanks for all of your posts and contributions to the board.
Many Thanks!
Chump
5Top that was 6 days ago. CYDY is ok, You Ok?
Chump
JPG77- I have no margin accounts. Only with Waters Parkerson New Orleans for 60+ years. I will check and thank you for the insight.
Chump
If you do let me know will also.
Chump
Good move
5Top. I don't know other than they have pressed. I have other no other guess but to say they have a plan I am very confident on. Very confident.
8 weeks orphans status and more will take us to where we should be.
Chump
I will say that I bounced CYDY off of a friend back in FEB. A brilliant retired physician before I got in. And he has always said Orphan status is the key here for CYDY. Damn smartest I get it quick guy I know. He's so right.
Let's see how it plays out.
Chump
crisg3616- Try it but I don't think your brokerage firm will honor that high of a GTC. Try 50+ an watch it as you should any stock.
That's bio techs, they can come out with surprises at any time.
Good Luck!
Chump
crisg3636-Someone put a post up a couple days ago that if your shares are at a price "Good till canceled" the shorts can't borrow them. Several of us on the board entered GTC at $50. If there is a R/S or anything spectacular I will cancel that order and adjust.
BTW- I do think we are worth $50 a share. Time will tell. Will be awhile.
Chump
Once again- IMO the resubmission for Orphan status is a key factor in the trading. The bids have been up to 200k plus since submission, never before. Someone is playing this but will run out of time. 100k buys will move this very well. As the FDA gets closer to their reply deadline we should start a move up. Everything from the last CC, CYDY establishing dedicated people to this and other things for the FDA was a good move. Just give the FDA the protocol paperwork/results and it's done. "disruptive and global"
CYDY could easily license or sell a portion for big bucks if Orphan Status is approved.
Chump
Ditto!!!
IMO- the best move CYDY has made is with re submitting for Orphan Status. That's money in the bank to start licensing if approved.
How longs the FDA approval?
My bet is they get it. Fingers crossed!
Chump
pphm_mike- Thanks for the post. I agree with the writer "no institutions" but disagree with "no short positions"
Thanks again!
Chump
265k vol on good news and were up a penny.Welcome to the OTC where there isn't MM's but dealers. Time to up list and quit waisting this good news on the OTC.
Chump
5Top- right link. A Tip from Chump off topic. Bookmark it for 2017.
Bigger than CYDY. Quantum computing needs it.
Chump
And a tip for those looking when they go public/ipo
http://lightfleet.com/983/lightfleet/stac-report-shows-lightfleet-fabric-has-highest-message-rate/
Chump
Watch us go up. Been here before. Results/data speak for the sp.
Chump
I'm not a moderator here but I will say from past experiences Qualcomm as one when i was in at $4. Longs, hang in there this will reverse. Week and half and can change everything. Finally, don't forget that this is "DISRUPTIVE" to BP. Hold tight! We will be rewarded.
Chump
Same here. $50.00
Get the feeling someone's trying to hold us at $1.08?
Ain't right!
Thanks Titan i like this also.."We have developed and validated a current good manufacturing practice (“cGMP”) process to manufacture PRO 140, through a single contract manufacturer, FUJIFILM Diosynth Biotechnologies U.S.A., Inc. This contract manufacturer previously produced multi-Kg scale bulk batches of PRO 140 under cGMP for our Phase 2 clinical studies and is capable of producing sufficient quantities of PRO 140 for all the clinical studies required prior to submitting a BLA to the FDA. In addition, we have undertaken certain comparability studies which supported the use of previously manufactured amounts of PRO 140 in current and planned clinical studies. This process has been completed and all PRO 140 drug substance can be used in our clinical trials."
FDA will like this.
Chump
D0Lphin- 1950 US Open Merion. 72nd hole. Ben Hogans famous 1 iron shot is us.
Beautiful!
http://image.nj.com/home/njo-media/width620/img/golf/photo/12915068-mmmain.jpg
Chump-old timer!
Awful quiet on the board today/tonight. Obviously, we've covered it all. Now the balls in he FDA and CYDY's court. Let's see what they can give us.
Here's to the longs!
hump
JPG77- Josh Mcguire has nothing to do as far as I know with seethruequity.
http://www.seethruequity.com/#!team/c23e7
A much bigger distinguished followers. No pump n dump.
Thanks!
Chump