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This might be a stretch of my opinion but if CYDY does follow through with some patient videos then I would think they have to be very confident that the FDA is as well acknowledging the results. Also, from the CC to say that videos and other activity will be picking up does make me feel they are confident about the results from the upcoming face to face with the FDA. I've said it before. This is a 5000 lb boulder about to slip off the cliff at anytime. A cliff hanger that keeps us on the edge of our seats. News can't be everyday but I think when it does the boulder will inch in our favor. As for R/S. Any strong catalyst announced won't need the R/S.
Staying long.
Chump
Eagle 1 Thank you! Time for Charlie to throw us another bone.
We need it.
Chump
Eagle1- yes I agree if we R/S institutions will buy in. I still think they can do it organically without the R/S which will bring more. The sit down with the FDA should be the deal breaker. If all is well we go up... if the same a R/S will be needed. I'm betting on the organic up list. Just my opinion and confidence CYDY has more to share.
Chump
I like the additional shares to avoid a takeover.
Good move!
Chump
bucky-your post is accurate. Mine is on the wishful side hoping CYDY will show some sign of change and move in an upward way instead of the past sideways behavior.
Chump
Fridays have been good for CYDY. Let's see how this plays out. 3 days of good vol and then nothing. IMO- a good buyers strategy.
Chump
You are correct that's what Seethruequity did!!
Also 18 weeks positive treatment behind Charlie gives him the fire power to really endorse this compassionate new alternative to the HIV community.
Waiting on it. Disruptive!
Chump
Ah! Nice day. Great vol last 3 days. Evidently an elephant has stuck his foot in the door. Obviously an adversarial move for the ones on the other side of the door with the sells on the ask. I don't think it's enough to stop the up tick momentum. I'm betting on the elephants. And don't think it had anything to do with the annual meeting. IMO- the results are hitting some radars. Could be a ride next week!
Chump
Sticking my neck out here but if we close tomorrow up 4-6 cents we could be on a tear in a week or so. Strong hands took over weak shares this AM. Great volume. A lot of traders out. A good sign. Still waiting on the other elephants to enter the room and I think they're coming based on the continued results. Also seems like Charlie has no problem with spreading the message for this cause. I respect that and thank him. HIV awareness needs more Charlie's.
Hoping for an up week! Betting on it!
Chump
Nice bone Charlie threw us. Now if he go would live here in the US with the same message would be awesome. Great article!
Chump
You are correct. They also will re-establish the agreement of submittal for BTD which in my opinion Dr P sounded confident. He made comparisons of other companies and how they reached BTD and where Pro 140 was meeting those same data results for approval. They have the results. I think a face to face meeting and a huddle up at the CYDY camp and this time it will fly.
Safe Harbor doing what its supposed to is all.
Face to face you can say we want is X, what do you need for it? etc.
Charlie could help us out about now. Wish he'd throw us a bone. He's been on treatment long enough to weigh in.
Chump
I had my finger on the call in for the CC. I wish I would have. I wanted to ask Dr P, Just to clarify this call are there any patients complaining of Pro 140? Are the results still the same as been published? Has the FDA expressed any negative sentiment of the current treatment of Pro 140? We know his answer would've been "no". Then I wanted to asked, then the only change has been with the submittal process and nothing from the current treatments? "Yes" Then I hope all the investors listening in understand that Pro 140 is holding up to it's treatment goals and that's what we are invested in.
Chump
Nice find, thanks! Monday will be interesting. The few I've talked to were the same as myself, invested in Pro 140 and it's results not affected by the CC. HC Wainwright on the call was a plus. Old Old Boston firm that handles some wealthy folks. I'm curious as to what activity Dr P said in the call will be happening.
Chump
This is so important and I think many are not realizing that the FDA is not questioning or saying the results or treatment is flawed. They are asking CYDY to follow each guideline for each request separately to move forward.
It seems CYDY submitted results that are so good that cover every application but the FDA wants them again separately.
Most important the results are not in question the application of them are.
Patient results are stellar and continue to be.
Chump
Realize the treatment results are the same, POSITIVE. The difference from yesterday is the FDA adding additional requirements. The only way this would have been negative is if the call said the results were failing.
They're not! And that's what I'm invested in.
And graph vs host is moving forward. A big plus!
If I was Charlie and listening to this I would be non responsive because he's made it clear as the other patients 2 yrs no viral loads feels the best ever on Pro 140 than any other treatment available.
Eventually we'll get up listed and in the hands of institutions that also recognize the results and don't mind the wait.
Can't wait for the patient videos to come out.
Chump
I think it was positive. The company is having results that no other treatment has obtained. It sounds to me the FDA is hand in hand walking them to the finish line with these added requirements not pushing them away. BTD is obtainable as Nader said.
Chump
drryan I agree..Thank you! sometimes ( and this is the sometimes) you can lead them to the trough and they still won't drink.
I can't wait till Monday am. Still on my $1.20+ tomorrow.
Trains a leaving. Up from here.
Chump
I'm still predicting a $1.20+ close Friday.
Chump
An annual meeting has been scheduled for next week and on it's agenda is a request to extend deadline for a r/s and proxy votes have been collected.
A company can't do an about face, schedule a CC to announce they just to decided to go ahead, wee changed our minds.
My thoughts they have a verbal approval they probably received in the last few days and scheduled the CC for Fridday knowing they will have received it officially by then.
Chump
The past 5-6 days...accumulation indicator was up. Why? Because there were 2 elephants trying to get through the door unaware of the other. Why the sell off? #1 elephant trying to drag the price down to scare some shares. Then the buy back. #2 elephant also at the door back up to 1.09. I'm waiting on the 3rd, 4th, and 5th to show now.
Seen this many many times. Block sizes getting larger, up ticks increasing.
My advice longs hold your pattern, shorts..no advice.
Chump
I don't know of a CEO that would make a non scheduled negative conf call. They would just put a PR out. It seems Nader schedules these when feedback from FDA is good. And the week before a vote/ annual meeting?? Positive!
Looking back 5-6 days at the accumulation I'm expecting spectacular news.
Also think the buying will be back for Thursday Friday ending above $1.20.
Look out Monday!
Chump
Wonder what it's about?
A reason to careful and due your DD. Especially day traders that rarely due DD just follow the hype. That's why CYDY is in such a good position and the long term play. DD is being done by our FDA.
http://www.bloomberg.com/news/articles/2016-08-15/a-35-billion-stock-was-just-halted-on-manipulation-concerns
d0lphin0m- your today's 1.10 hold request did and add 2 cents. I'm sure you'll bake that in soon with an update when it picks up some more. I'm hoping for some 500k vol days, bigger blocks, and bids. When your tea leaves start arranging please do share them.
Chump
Exactly 5TOP many types of HIV indications to address with the need for more than a "cure all" for now. Pro 140 has test results of it's compassionate results. Enough of a market to attract a buyout. Eliminating the symptoms, providing quality of life. Worth a peek by some Big Pharmas.
Balls in the FDA's court any day till Sept ish.
Chump
Infusion treatment. Not apples to apples. They're competing with some other infusion treatments. Only disruptive for the patient, accessibility, costs and combination toxicity back lash.
Chump
I'll break the ice, I expect the same accumulation to $1.18 this week maybe more. Orphan Status and BTD approval would be a Disney scenario for a buy out. The bigger block trades are for holding not trading another indicator somethings brewing. We're not the sex a peal darling stock ...YET!
Chump
Maybe Seethruequity's update on $3.40 is getting in the right hands. Orphan Status from the FDA puts us around Sept 12-13 or any day sooner.
I expect a pick up. I like that the block sizes have increased. This week has shown many 10k blocks vs 100's. I don't chart but love the input, thanks! I watch the green block sizes. Day traders don't buy 10k blocks.
Chump
Thanks 5Top..with news on Orphan Status and BTD we could catch em in a snare. I think someone got called out yesterday especially with the 140k block at .98 or so. Reason vol was lower today. People collateral against their accts etc. and the banker tells the broker I need x amount of funds and the broker just sells what he decides. My guess only because we haven't had anything but good news in the past months.
Chump
The selling. I can't blame some folks. I'm up 25-28% on my buy in at .78-82 and could sell at today's sp and move on. Other's do this. They see a 20% return on their money and are happy. I'm in this for more than 20%. Waiting on Orphan Status and possible BTD. Hopefully any day. HIV is a high priority on the FDA's check list. This shouldn't drag out.
Watch the bids this week.
Chump
I believe the 2 weeks/submittal...reply etc. is up or close to up. I expect buying starting this week.
“We believe the construct of the treatment-naïve population trial demonstrates how different PRO 140 is compared with all other approved HIV drugs. PRO 140 is in a unique new class because it is the first self-administered, subcutaneous injectable antibody that could decrease the viral load of an HIV patient by as much as 1.65 log 10 by way of weekly injections in just three weeks.”
Dr. Pourhassan added: “We are pleased with our ability to continue to identify additional new and innovative opportunities to advance PRO 140 along multiple concurrent paths toward approval. We believe this treatment-naïve path offers many advantages to CytoDyn to potentially receive its first approval from the FDA for use of PRO 140. CytoDyn has now positioned PRO 140 in two Phase 3 trials for chronic conditions in two different HIV patient populations and one clinical trial in acute condition for HIV.”
Chump
My guess before Labor Day.
Chump
The market will get this and is WHAT'S UP with the buying:
CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140 of Treatment-Naïve HIV Patients
PLANNED 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:
1. 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.
CytoDyn President and CEO, Nader Pourhassan, Ph.D., commented: “We believe the construct of the treatment-naïve population trial demonstrates how different PRO 140 is compared with all other approved HIV drugs. PRO 140 is in a unique new class because it is the first self-administered, subcutaneous injectable antibody that could decrease the viral load of an HIV patient by as much as 1.65 log 10 by way of weekly injections in just three weeks.”
Dr. Pourhassan added: “We are pleased with our ability to continue to identify additional new and innovative opportunities to advance PRO 140 along multiple concurrent paths toward approval. We believe this treatment-naïve path offers many advantages to CytoDyn to potentially receive its first approval from the FDA for use of PRO 140. CytoDyn has now positioned PRO 140 in two Phase 3 trials for chronic conditions in two different HIV patient populations and one clinical trial in acute condition for HIV.”
2. Antiretroviral therapy (ART) is treatment of people infected with human immunodeficiency virus (HIV) using anti-HIV drugs. The standard treatment consists of a combination of at least three drugs (often called “highly active antiretroviraltherapy” or HAART) that suppress HIV replication.
3. The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders and many other organizations,[7] is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market.[8] Under the ODA drugs, vaccines, and diagnostic agents would qualify for orphan status if they were intended to treat a disease affecting less than 200,000 American citizens. Under the ODA orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), "tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance[5]:660 and may get clinical trial tax incentives.
4. I. Request for Designation (RFD) Processing Measures
A. Ensure filed RFDs are reviewed within statutorily mandated 60 day timeframe
What Orphan Status means to us...Tax credits
https://www.washingtonpost.com/business/economy/high-prices-make-once-neglected-orphan-drugs-a-booming-business/2016/08/04/539d0968-1e10-11e6-9c81-4be1c14fb8c8_story.html
Chump
When I say more is brewing....I mean if CYDY if very confident they will get Orphan Status approval then deals for licensing/partnership etc should be in talks. Between now and Labor Day should be real fun.
Cump
This week was interesting. The sellers were obviously here but there was buyers as well. I expect the next 4-5 weeks the buying will pick up like today. Orphan Status or any approval from the FDA means they will make money. This is exciting.... Up List and annc Orphan status approval, that would take us to new levels. I'm sure there's more brewing.
Chump
drryan- I completely agree. FDA approval on anything means potential money. Licensing, partnership will follow. Any time between now and Labor day we should hear something that puts a much higher SP than where we are. Just a few weeks. I personally think that Orphan Status approval with licensing deals will put us over $3. Organically. But do a split then annc the FDA approval and lord knows who will jump in.
Good Stuff!
Chump