Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I thought Jboatswain and Martygx were the same person.
Misiu I agree with you.
Who are join giving all the info to?
JJAA: I don't want to give you wrong info so I would recommend you read post # 10029 from MISIU and if you go back to post 10000 and read from there you will probably get all the info you are looking for.
I would highly recommend you go directly to the source, go to News and & Events:
http://www.cytodyn.com/
you can check out this site also:
https://aidsinfo.nih.gov/clinical-trials/search/b/0/pro140
Good luck.
Breakthrough Therapy Designation.
Here is an excerpt from the FDA website:
"Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
A breakthrough therapy designation conveys all of the fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review."
You can read more here:
https://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm
Not all dentist are broke. I know successful ones
To get his message across under a different name....
Misiu I thought pro140 was suppose to a substitution, with the patient alternating with HAART or in other words give the patient a break from HAART. I am sometimes confused myself...
Wow. What a turnaround when we seek help from some1 who may or may not be on board! Not so sure any1 can rely on Pears!
Did you check your email? It was email to me by Ameritrade with the prospectus and the offer sheet.
Did any1 listen to it?
Yes. I took the full amount that was offered to me. First time buying warrants so I'll see how it pans out.
CytoDyn Inc. CYDY is a biotechnology company that could be an interesting play for investors. That is because, not only does the stock have decent short-term momentum, but it is seeing solid activity on the earnings estimate revision front as well.
These positive earnings estimate revisions suggest that analysts are becoming more optimistic on CYDY’s earnings for the coming quarter and year. In fact, consensus estimates have moved sharply higher for both of these time frames over the past four weeks, suggesting that CytoDyn could be a solid choice for investors.
Current Quarter Estimates for CYDY
In the past 30 days, 1 estimate has gone higher for CytoDynwhile none have gone lower in the same time period. The trend has been pretty favorable too, with estimates rising from a loss of 5 cents a share 30 days ago, to a loss of 4 cents per share today, a move of 25%.
Current Year Estimates for CYDY
Meanwhile, CytoDyn’s current year figures are also looking quite promising, with 1 estimate moving higher in the past month, compared to none lower. The consensus estimate trend has also seen a boost for this time frame, rising from a loss of 19 cents per share 30 days ago to a loss of 17 cents per share today, an increase of 11.8%.
CytoDyn Inc. Price and Consensus
CytoDyn Inc. Price and Consensus | CytoDyn Inc. Quote
Bottom Line
The stock has also started to move higher lately, adding 5.8% over the past four weeks, suggesting that investors are starting to take note of this impressive story. So investors may definitely want to consider this Zacks Rank #2 (Buy) stock to profit in the near future. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Click here for Zacks' private trades >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
CytoDyn Inc. (CYDY): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
Divide the amount of your shares by 20 and that's the amount qualify to buy. Then fill out the form online and check the box that states if they lower the price to buy more...I think it's option 2. Make sure you have enough in your acct to cover the transaction. Ameritrade called me today and that's what they told me. Hope this helps.
We all figured that out...lol
If you figure it out let me know...I sold most of mine and only have a small amount left.
I really don't know. To be honest I don't even know how to fill out the form.
I got some shares in my account with a title "Non Taxable Spin Off/liquidation distribution" and I know it's related to PVCT. Anyone knows what it's all about?
I got an offer from Ameritrade also. Think I'll pass on it though.
Did anyone get an offer to buy shares ?
jboatswain You don't see this as directly going after Misiu??
"Dr. M. WITH ALL DUE RESPECT, ARE YOU A PSYCHIATRIST? What are your credentials...you must be retired since you are on this board a lot. TIA"
It's ok for him to post his opinions, however farfetched some of them are but asking if Dr. M is a PSYCHIATRIST, for her credentials and "you must be retire since you are on this board a lot" is a cheap cut at the Dr.
Dr. M is a valuable contributor to this board and now no longer wish to contribute because of him. We all have learned a lot from Dr. M.
Pears really need to relax. It seems his intention is to discredit, insult and disrupt. It did seem like he was intentionally going after Misiu a valuable contributor to this board.
Please don't leave...I enjoy reading your post.
I meant to say 'Didn't'
Mmmmmmmm..... they can't get something as simple as that correct!
CytoDyn Inc logoHC Wainwright set a $2.00 target price on CytoDyn Inc (NASDAQ:CYDY) in a report published on Wednesday morning. The firm currently has a buy rating on the stock.
I don't know CYDY was listed on the NASDAQ?????
Timeline????
According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is December 2017. The estimated study completion date is March 2018.
Anyone think buyout is possible before completion date?
Seeking Alpha article that mentions CYDY
Gilead: M&A Coming Soon
Dec. 2, 2016 11:32 AM • GILD
"Even in HIV, where Gilead will likely be ceasing further R&D research beyond what is currently in the pipeline, there are targets such as CytoDyn's (OTCQB:CYDY) PRO-140 that offer different mechanisms by which to fight the virus and offer less hepatotoxicity concerns than existing HAART drugs. And on the long-acting (LA) treatments, John Milligan, CEO of Gilead, even mentioned during the Piper Jaffray conference that LA treatments in HIV patients may have better efficacy in a real world setting where patients are more likely to forget to take pills. This can add value to payers, as negligence becomes less of a concern (and which is nearly impossible to measure in clinical trials)."
Full Article:
Gilead: M&A Coming Soon $GILD http://www.seekingalpha.com/article/4027844
SEC Filing Alert
4: Statement of changes in beneficial ownership of securities
http://ir.cytodyn.com/all-sec-filings/content/0000899243-16-034017/form4.html
CytoDyn’s Two-Year Update on Its PRO 140 Monotherapy Study in HIV Accepted at CROI 2017
VANCOUVER, Washington, Nov. 16, 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 an abstract featuring results from its ongoing Phase 2b extension study with PRO 140 as a monotherapy for the treatment of patients with HIV has been accepted for a poster presentation, as well as a “themed discussion” at the Conference on Retroviruses and Opportunistic Infections (CROI), which is being held in Seattle from February 13 to 16, 2017.
The abstract, “PRO 140 Single-Agent Maintenance Therapy for HIV-1 Infection: A 2-Year Update," was selected for a Themed Discussion Presentation by the CROI Program Committee. This presentation will include four or five abstracts merged into a special theme-oriented, hour-long discussion featuring a brief summary of noteworthy results, conclusions and discussion points. The presentations will be followed by an interactive discussion that synthesizes the relevant information of the abstracts, covers key points of agreement and controversy and draws comparisons to related work in the scientific field.
The abstract will provide an update on 10 patients with HIV who have successfully achieved complete viral load suppression for more than two years with PRO 140 administered in weekly subcutaneous injections. Complete virologic suppression is defined as plasma HIV-1 RNA less than 40 copies/mL, which is the lower limit of detection in the commercial assay for HIV detection and is the level at which HIV transmission is reduced by more than 96%.
“The results from this ongoing extension study are highly significant as PRO 140 is being substituted for the current standard of care Highly Active Antiretroviral Therapy (HAART),” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Only about 30% of patients achieve lifelong viral load suppression on HAART, which also has notable drawbacks such as highly regimented daily dosing, toxicity and incomplete recovery of the immune system. All patients in the Phase 2b monotherapy study were evaluated for infection with strains of HIV-1 that utilize the CCR5 co-receptor as PRO 140 targets CCR5 with high affinity and potently blocks HIV-1 cell entry.
“We look forward to having results from our ongoing extension study presented to the many researchers and others involved in HIV/AIDS who will be attending CROI 2017,” added Dr. Pourhassan. “We are advancing PRO 140 through the clinical development process both as a monotherapy and in combination with HAART. We anticipate announcing our primary efficacy endpoint results from the pivotal Phase 3 combination trial as early as the first quarter of 2017.”
CROI Conference
The annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational and clinical researchers from around the world to share the latest studies, important developments and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI is a global model of collaborative science and the premier international venue for bridging basic and clinical investigation to clinical practice in the field of HIV and related viruses. Additional information about the conference is available at http://www.croiconference.org/.
WallStreet I have a polish friend by the name of Natalia also. She lives in NJ.
CytoDyn Investment Community Presentation
The presentation by Dr. Nader Pourhassan, President and CEO, will address previous public disclosures regarding CytoDyn's Phase 3 combination therapy trial protocol modifications and timelines for other initiatives.
http://www.cytodyn.com/media/press-releases/detail/246/cytodyn-announces-webcast-of-investment-community
Sorry I confused you with WallStreet
Don't you have 90,000 shares??
This is the only sane thing I have heard Donald Trump say recently:
Donald Trump delivered a long list of things he would do if elected president.
28 Things he Promises to Do as President:
#23 "Work with Congress on a Repeal and Replace Obamacare Act, Fully repeals Obamacare and replaces it with Health Savings Accounts, the ability to purchase health insurance across state lines, and lets states manage Medicaid funds. Reforms will also include cutting the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications."
CytoDyn Files Protocol for Extended Access to PRO 140 for Patients Who Reach the End of PRO 140 Pivotal Phase 3 Trial
Download PDF
VANCOUVER, Washington, Oct. 24, 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, announced today that it filed a new roll-over protocol allowing all ongoing patients who reach the end of the Phase 3 combination study to continue receiving PRO 140.
The primary intent of this roll-over protocol is to provide PRO 140 for a second patient, who has completed this study, and all other future patients who complete participation in the Phase 3 combination study and would require continued access to PRO 140 to form a viable regimen, in the judgment of the treating physician.
CytoDyn submitted, and received, a single-subject compassionate use protocol when the first patient completed the Phase 3 combination study and the treating physician requested continued access to PRO 140 in order for the patient to continue deriving clinical benefit and to maintain HIV-1 viral suppression.
The Company expects that other clinical sites will have the same request, as the patients enrolled in the Phase 3 combination study are heavily treatment experienced and may require continued access to PRO 140 to maintain viral suppression. Therefore, CytoDyn decided to submit a new roll-over protocol that would allow all ongoing and future patients who successfully complete one week of efficacy followed by 24 weeks of safety treatment with PRO 140 under the Phase 3 combination study to receive continued access to PRO 140.
CytoDyn recently announced that following a meeting with the U.S. Food and Drug Administration, the Company reduced the number of patients required for its Phase trial to thirty (30) patients. In addition, the primary endpoint was reduced to a viral load drop of 3 fold (0.5log) from a drop of 5 fold (0.7log). Furthermore, data from CytoDyn’s second monotherapy trial (with first patient dosing expected in 2016) will be used for the safety portion of the Phase 3 combination therapy trial.
Dr. Nader Pourhassan, President and CEO, commented: “Investigators in the ongoing Phase 3 combination trial have expressed a medical need for enrolled patients to remain on PRO 140 in order to maintain a suppressed viral load.” Dr. Pourhassan added: “We are pleased that our primary endpoint results for this pivotal Phase 3 trial could be achieved by the first quarter of 2017. In addition, we are encouraged by the lowering of the primary endpoint to a viral load reduction of 3 fold after one week, which compares favorably to the 10 fold to 20 fold viral load drop demonstrated by PRO 140 in three previous clinical trials with the same or less dose of PRO 140 in one week.”
http://www.cytodyn.com/media/press-releases/detail/245/cytodyn-files-protocol-for-extended-access-to-pro-140-for
I can't even fathom what it would mean to you with your +400k shares if this goes to $15-$20 per share.
Good for you! I'm holding waiting for the big pop!
Good. I see you are one of those with patience!
You will be smiling all the way to the bank! For all of us...lol
I meant "for your belief' not 'believe'