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Hope have deep pockets katmandu aka mr short
with what's coming down the pipe including a late stage ii proven effective (and safe - without side effects) novel hiv therapy that can be used at all stages ... best of luck to you. You did read the years on those right?
$1.45 to $2.99++
Friday's close $1.45, a big jump last week. Anticipating upcoming news I presume. Price last year this time $2.99 with just Cytolin product (no PRO 140).
http://finance.yahoo.com/q/hp?s=CYDY&a=10&b=17&c=2005&d=10&e=11&f=2012&g=m
Wonder if we fly by $3 after $6 million NIH grant and restart phase IIb trials announced?
Rumor shareholder meeting December - last shareholder meeting revealed this,
"Also during the meeting, Dr. Jen of MGH said for us to hold tight. We got something quite unique and that Cytolin works. What MGH wants to know in this study is why does Cytolin work?"
http://finance.yahoo.com/mbview/threadview/?&bn=bf371882-82e6-3a22-91b2-b4518ede4c52&tid=1289241472000-19b61d94-9885-39f8-9813-01e386238ab9&tls=la%2Cd%2C84
So - you have $6 mil grant, phase IIb trials and Dr Rosenberg's publishing on Cytolin's mechanism imminent - all could put CYDY on a world stage.
Gilead Scores Record Profits ...
10/24/12 report:
Analysts note that sales of AIDS drugs Atripla were up 9% and Truvada sales up 8% as Gilead announced third quarter revenue was up 14% overall to $2.43 billion and the company raises its full year sales forecast to $9.2 billion.
gilead certainly has cash to get jump on monoclonal antibodies (AIDS next generation of treatment) to maintain their lead in HIV/AIDS market ...
or maybe competitor like Pfizer, Bristol-Myers or GlaxoSmithKline (all who have billions of cash on hand) will look to cut into Gilead's $9+ billion in yearly sales by acquiring CytoDyn, the world leader in HIV monoclonal antibodies
http://aidsinfo.nih.gov/contentfiles/ApprovedMedstoTreatHIV_FS_en.pdf
PRO 140 Phase IIb Trials
PRO 140 has already shown to be most potent single agent developed to treat HIV infection after being evaluated in three clinical trials according to Dr Trauger.
Phase IIb trials will determine optimum dosing schedule, mode (pen injection vs subcutaneous injection) and frequency. PRO 140 was previously administered once-weekly, but dosing may be possible with a two week or monthly schedule.
PRO 140 appears to work at every step of HIV/AIDS treatment from prevention to salvage ... for those who've developed resistance to the only other CCR5 entry inhibitor, Viiv Healthcare's Selzentry (maraviroc). Viiv is the HIV joint venture between Pfizer & GlaxoSmithKline. PRO 140 is their solution.
So, you've got a 1 + 1 = 3 scenario ...
PRO 140 immediately helps those in salvage as well as being supplement to current antiretrovirals. Cytolin has Phase I efficacy and safety data - Dr Rosenberg's study under peer review which will reveal how it works. Imagine a super monoclonal antibody drug, 'Pro Cytolin' ... help those who developed resistance or just can't handle the antiretroviral side effects and probably most importantly, could be a 'working vaccine.'
And as we've seen of late, big pharma comes a calling when it's seen phase IIb data.
CytoDyn moves biotech operation to Lake Oswego, Oregon
"CytoDyn is also close to completing a $7 million fundraising round — it’s about $1.3 million short of raising the full amount, which CytoDyn hopes to land through through equity, debt and options, according to filings with the Securities and Exchange Commission — and announced last week it has purchased a potential HIV therapy from a New York pharmaceutical company." PRO-140
http://www.bizjournals.com/portland/news/2012/10/23/cytodyn-moves-biotech-operation-to.html?ana=twt
PRO140: A Game Changer for People with HIV
"PRO-140 is a step forward, and represents a game changing type of therapy.
Many who cannot successfully keep their virus under control with their existing medicines could get it under control adding PRO 140 because PRO-140 need only be taken once every two weeks or so and could be given to a patient at a clinic on a regular basis so that health care providers could be aware of any missing doses.....
Many who have side effects from their medicines might be able to switch out of problematic choices in favor of PRO-140 and be free from the side effects."
read more ...
http://searchforacure.org/index.php?option=com_k2&view=item&id=58:pro140-a-game-changer-for-people-with-hiv&Itemid=67
Yes, a BIG step in the right direction toward endgame (attract Big Pharma) ...
To do list:
Announce $6 million NIH grant
Start phase iib trial(s) ASAP
Dr Rosenberg publish Cytolin mechanism of action study
Keep CytoFeline moving along
.... release phase iib trial findings as come available to pfizer, gilead (they and others literally sitting on tens of billions of dollars & looking to replenish pipelines as existing patents and profits start to expire)
I predict we will see new buyers of CYDY in the coming weeks who today have never heard of CytoDyn
Imminent news of CytoDyn's PRO-140 acquisition makes them the leading HIV monoclonal antibody biotech in the world.
Deal also comes with a $6 million dollar NIH grant that arrives this month and allows for immediate recruiting of phase 2b trials ...
Several phase 2b antibody biotechs have been scooped by big pharma this year ... just last 6 weeks:
8/30/12 J&J buys monoclonal antibody drug (phase i/ii) for $1.1 billion ...
9/6/12 Merck snags phase ii antibody drug for $625m ...
9/19/12 Novartis has its eyes on SelG1, an antibody headed into a mid-stage study for vaso-occlusion up to $665 million
9/18/12 MacroGenics, which could reap up to $1.1 billion in payments from Servier in the deal for bi-specific antibodies
10x Buyers vs Sellers, Another Volume Spike Today
Appears more and more believing we are close to substanial news
Volume spike last 2 days, good news coming?
Long overdue ... let's hope so!!
Today's news release:
Nader new interim CEO and Dr Trauger new Chief Scientific Officer.
note: Dr Trauger previously mentioned the PRO 140 $6 million grant transferable as early as next month (Oct).
editorial portion: heard (rumor) fund raising via note selling going well for the PRO 140 acquisition so news of this being finalized could provide nice pop.
Last week's conference call revealed
Dr Rosenberg finished his study and has written his findings on Cytolin's mechanism - currently in peer review (exact publishing date unknown)
PRO 140 acquisition and ongoing company admin costs require immediate raising of $5 mil - Gould/NP already raised $800k and have approx 50 days to raise rest. Company is having good luck selling notes to raise the money. May consider private placement down the line if stock rises.
CytoFeline's 30 day study at CSU underway - date for published findings (if warrant) unknown
New CEO search underway but appear to leaning to Nader
PRO 140 acquisition comes with a $6 million dollar transferable grant
Gould made it clear management intends to communicate much more with stockholders going forward
What's Next?
Secure $5 mil for Pro 140 acq and ongoing admin costs of running company... take advantage of FDA's fast-track designation for PRO 140 for new super drug 'PRO Cytolin' to initiate 24 week phase II clinical trial ...
Meanwhile Dr Rosenberg publishes affirming efficacy as well as mechanism of drug ....
Big Pharma begins to take notice
And then there's FIV, just considering it bonus at this pt
Overly simplistic and optimistic ... maybe, but appears to be a real possibility
Feels like momentum is building.
Volume hitting six figures every day now(4 to 7x daily avg) and stock price rose today approaching dollar before settling back.
Van Ness said PRO 140 acquisition comes with multi million dollar NIH grant.
If news that the PRO 140 acquisition has been finalized can be coupled with results of Dr Rosenberg's findings, oh my ...
Volume up, price down ... what's next?
Massive spike in trading volume this week going high as 400k on Thursday (daily avg had been 30k) - appears institutional investors getting involved.
If can add some company news (Dr Rosenberg report, FIV, Pro-140, etc) then watch out.
Dr Rosenberg Where Are You????
Appears CytoDyn contractually paid Dr R all monies due late last year yet we still await his report/findings. Does he at least provide updates to Dr Trauger or K Van Ness?
I can only hope the yet-to-be-announced shareholder meeting sheds light on this, Pro-140 acquistion, CytoFeline, financing ....
"On May 24, 2011, CytoDyn Inc. (the “Company”) issued a press release announcing that the Company and The General Hospital Corporation, d/b/a Massachusetts General Hospital (“MGH”) entered into an amendment (the “Amendment”) to their September 28, 2009 Clinical Trial Agreement to extend the original study entitled, “An observational study to determine the in-vitro immunologic and virology activity of Cytolin.” The Amendment will enable MGH Principal Investigator Eric Rosenberg, M.D. to further explore his initial findings regarding the potential mechanism of action of Cytolin to treat HIV-positive adults. The Company has agreed to pay MGH the remaining unpaid balance of $291,590.00 of the total research grant of $865,375.00 over the next six months, at which point the Company currently anticipates the extended study will be complete, although there is not a contractual obligation to do so in that timeframe."
http://www.sec.gov/Archives/edgar/data/1175680/000119312511149317/d8k.htm
Agreed, at dollar a share that's heck of a value for a company with a drug that could revolutionize HIV/AIDS treatment.
-- Let's hope CytoDyn brass break their silence soon --
10k, good news announcement, proxy, shareholder meeting?
Being that fiscal yr end was May 2012, I can foresee such a scenario ...
plug in stock boost as well
Good video on how Cytolin works ....
http://vimeo.com/11663036
Some game changing stuff that's for sure - just need Dr R and his report to validate then we're off to the races. CytoDyn will be only drug of its kind and BEST treatment option for this multi-billion dollar market. Big pharma will fight over.
PRO 140 acquisition news any day now ....
could provide boost and erase recent stock erosion. Van Ness said it may come with 2 NIH grants. It also bolsters pipeline adding a drug already in Phase II that's been 'fast tracked' by FDA.
World soon to have first HIV vaccine
according to this headline from Unaids out of Manilla ...
maybe this brings cause to forefront and helps expedite big pharma taking notice of Cytolin and Pro 140
http://www.manilatimes.net/index.php/news/top-stories/23430-world-soon-to-have-first-hiv-vaccine--unaids
How much is CytoFeline worth?
LUTZ, Fla.--(BUSINESS WIRE)--
CytoDyn Inc. (the "Company")(OTCQB:CYDY.PK - News), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency virus and other antibody applications, announced today that the Company completed production of a sufficient amount of CytoFeline™, a monoclonal antibody developed by the Company for the treatment of Feline Immunodeficiency Virus ("FIV"), to allow the Company, through its wholly owned subsidiary, CytoDyn Veterinary Medicine LLC ("CVM"), to move forward with the next stage of the antibody's development. When purification of the antibody is completed, CVM will conduct in vivo efficacy tests in cats to determine the practicality of anti-LFA1 antibodies to lower viral loads in FIV-infected cats.
CVM has selected Colorado State University and Dr. Susan VandeWoude, DVM, Associate Dean for Research CVMBS, Professor of Comparative Medicine, DMIP, at Colorado State University to lead the CVM's continuing research of CytoFeline™, and to conduct these additional efficacy tests. "CytoFeline™ potentially represents an exciting new anti-retroviral therapy for cats with FIV. We will be testing its potential to be used in cats infected with FIV, and hope that our studies will provide a new therapeutic option for cats suffering from this disease," commented Dr. VandeWoude.
Initial CytoFeline™ research was performed in the laboratory of Dr. John Elder, Ph.D, Professor in the Department of Immunology and Microbial Science at The Scripps Research Institute. The Company anticipates that Dr. Elder intends to publish a paper discussing the results of his research when the research is completed.
"CVM looks forward to being able to commence the next stage of research of CytoFeline™, and to continue to explore the FIV model as a potential stand-alone business opportunity," commented Kenneth J. Van Ness, President and Chief Executive Officer of the Company.
Progenics May 8th conference call, first qtr results
Wonder if we will get an update on CytoDyn's PRO 140 acquisition?
http://progenics.com/releasedetail.cfm?ReleaseID=670486
Big pharma paying premium to refill their pipeline
“It’s a good time to be a seller if you’re a biotech company .....Acquirers have been willing to pay 71 percent more than a biotechnology company’s average 20-day stock price in deals greater than $500 million this year, the highest average premium since at least 2000....
...Of 104 drugs with U.S. patent protection expiring between 2012 and 2016, 44 percent will lose exclusivity this year and next, according to data compiled by Bloomberg....The biotech companies have become the research arms of a lot of these large pharmaceutical companies ... They’re willing to let the biotech companies do the leg work to start out and then they’re swooping in with large premiums ... "
http://www.bloomberg.com/news/2012-04-24/human-genome-most-lucrative-on-record-biotech-premiums-real-m-a.html
Hold your hats, i sense very good news knocking at doorstep
Have feeling many more announcements coming very soon.
What kind of news propels share price?
Income (FIV)
Dr Rosenberg report
Grant(s)
Cytolin jumping to phase 2 trials.
Yesterday's conference revealed the following possible/likely 2nd qtr actions (next 2-10 weeks):
1) Pro 140 acquisition which may include 2 NIH grants
2) Pro 140 has been given FDA fast track designation (completed phase 2a trail so may move Cytolin as well)
3) Middle East grant(s) and/or financing
4) Hire Investor relations firm for more stock exposure
5) Pre-IND meeting
6) Dr Rosenberg's (Mass Gen Hospital) wrap up of his study of Cytolin's mechanism / Confirmation of companies current working science knowledge
7) Dr Elder's (Scripps) update on his FIV/CytoFeline research
8) CytoFeline pilot study with infected cats
9) Other strategic focused diversification cashflowing opportunities (see today's filing re: building purchase to accommodate future growth and provide income)
Conference link http://www.wsw.com/webcast/wsaf20/cydy/
If CytoFeline production announced, any prediction on how much CYDY rises?
Agreed - I think our sub 3 days are closing fast. We have lots to be excited about over the next few days, weeks and months!
Combined Phase 3 Trial Approach, Cytolin & PRO140?
Interesting take from poster on yahoo board:
I read the transcript from Jan 13 along with this 8K and I'm puting the pieces together.
PRO-140 binds to CD4
Cytolin binds to CD11A
These are 2 different Monoclonal approaches to blocking HIV.
At the meeting there was significant talk about combining 2 monoclonal treatments into one monoclonal cocktail and therefore creating a stronger, more broad based treatment that can happen monthly in lieu of weekly. David Scondras even suggested that the States just take over the research since Progenics was bailing on the drug (in order to concentrate on their cancer drugs).
With PRO140 being basically thrown in the garbage by Progenics, CYDY appears to want to take over the PRO140 Phase 2 trials and eventually proceed with a combined approach.
Ideally, and I don't know if the FDA will even allow this, but if they can complete Phase 2 trials with PRO140 and show it works, which the transcripts specifically state that "it works," then they would be able to do phase 3 trials with a combined approach of PRO140 and Cytolin. If this is allowable, VanNess may have just maneuvered his way into a fast track for Cytolin and made it stronger at the same time.
Any info on whether the FDA would allow this scenario to play out would be helpful.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_C/threadview?m=tm&bn=76036&tid=221&mid=225&tof=1&rt=2&frt=1&off=1
CytoDyn's PRO 140 Granted FDA Fast-Track Approval
Phase II - PRO 140 has been granted fast-track approval from the FDA and will need to be proven in large, long-term high-quality randomised controlled trials (RCTs).
http://blogs.terrapinn.com/exploratory-clinical-development/2012/03/09/promising-hiv-treatments-early-development-part-1/
WOW
What's Next for CytoDyn, Big Jump Coming Soon?!
Here's a couple possibilities: A large grant or Big Pharma stepping in to fill their pipeline?
Monoclonal antibodies represent the future of long-term antiretrovirals (ARVs).
So why do monoclonal antibodies last so long in the body? The answer is because they are what the immune system naturally produces to fight infection, so your body is used to them being around. Short-term ARV's, like what we have now for HIV, are small molecules that the body is not used to having around and rapidly disposes of.
Very few people are working on monoclonal antibodies for HIV. But the first three antibodies actually used in people are Ibalizumab, PRO-140, and Cytolin. Progenics and their PRO-140 has dropped its program and is looking for someone to adopt the antibody and finish testing it. Ibalizumab is in its second generation of effort, having been dropped by companies before, and has been stagnant for the past two years despite a 24.7 million dollar grant from the Gates foundation.
http://www.rockefeller.edu/research/faculty/labheads/DavidHo/
Cytolin is the only drug being developed by a company still determined to see a monoclonal antibody become a tool for our community to use to fight HIV.
http://searchforacure.org/index.php?option=com_k2&view=item&id=51:antibodies-and-aids&Itemid=67
What's next for CytoDyn??
Remember this January news release:
ISMAIL ABDUL FATTAH AGREES TO BECOME CYTODYN'S SENIOR ADVISOR OF BUSINESS DEVELOPMENT FOR THE MIDDLE EAST
Lutz, Florida, January 18, 2012 – CytoDyn Inc. (the "Company")(OTC QB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, and other antibody applications, announced today that Ismail Abdul Fattah will serve as the Company's Senior Advisor of Business Development for the Middle East. Mr. Fattah will continue to serve in his role with AM Financials s.a.l, in Beirut, Lebanon. As part of the Company's evolution and international business development activities, Mr. Fattah will work in conjunction with Dr. Nadar Pourhassan, the Company's Managing Director of Business Development, to expand the Company's business development activities in the Middle East.
"The Company is pleased and honored to have Mr. Fattah advising on sponsorship and business development opportunities in the Middle East," commented Kenneth J. Van Ness, President and Chief Executive Officer of the Company.
"I am optimistic that my experience will complement the Company as it progresses its scientific and business opportunities in the Middle East, and I look forward to expanding our relationship in the future," commented Mr. Fattah.
http://cytodyn.com/news-and-events.aspx
Dr Ho and his Ibalizumab received a $24.7 million grant. Why couldn't CytoDyn receive similar - whether it's from a middle east foundation or somewhere else in the world, I see this as a real possibility.
Other option ... Big Pharma stepping up and buying as they are sitting on tons of cash and looking to fill their pipelines.
"Billions of Big Pharma cash sits in figurative coffee cans around the world, waiting for executives to feel ready to spend. Some companies are saving up for the right acquisition to come along .... the cash-rich drugmakers are Merck, which has stashed away an additional $1 billion this year. Johnson & Johnson has added another $3 billion to its stores, the newspaper reports, giving it some $27 billion on hand. Pfizer has beaucoups cash, $24 billion as of last week..."
http://www.fiercepharma.com/story/merck-pfizer-among-cash-stashers-markets-gyrate/2011-08-09
I can only imagine what happens to CYDY with either?
Cytodyn (CYDY) and it's Cytolin an HIV Vaccine?
Three New Medicines for HIV
Antibodies to treat HIV has been talked about among scientists and papers have been written about the idea since at least 2003. But the first three antibodies actually used in people are Ibalizumab, PRO-140, and Cytolin.
"Very few people are working on monoclonal antibodies for HIV. Progenics has dropped its program and is looking for someone to adopt the antibody and finish testing it. Ibalizumab is in its second generation of effort, having been dropped by companies before, and has been stagnant for the past two years. Cytolin is the only drug being developed by a company still determined to see a monoclonal antibody become a tool for our community to use to fight HIV."
http://www.searchforacure.org/index.php?option=com_k2&view=item&id=51:antibodies-and-aids&Itemid=67
Pretty powerful stuff, imho
Powerful testimonial from someone who took Cytolin:
http://searchforacure.org/index.php?option=com_k2&view=item&id=35&Itemid=146#comment-464805172
Spike in volume today, 3x daily average ....big news coming next week??
http://finance.yahoo.com/echarts?s=CYDY.PK+Interactive#symbol=cydy.pk;range=1y;compare=;indicator=volume;charttype=area;crosshair=on;ohlcvalues=0;logscale=off;source=undefined;
Remember this release ....
January 13, 2012 – CytoDyn Inc. (the “Company”)(OTC QB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency virus and other antibody applications, announced today that it is presenting an update on its Human Immunodeficiency Virus (“HIV”) and Feline Immunodeficiency Virus (“FIV”) therapeutic antibody programs, including new preclinical findings, at the Therapeutic Potential of Antibodies for HIV meeting sponsored by Search For A Cure, Inc. in Boston, Massachusetts
http://www.sec.gov/Archives/edgar/data/1175680/000119312512012072/d281758dex991.htm
The January meeting was recorded but needed to be transcribed and scrubbed for proprietary information that the participants may be under contract to not disclose publicly. Apparently details are set to be revealed at the March 15th Aids Project in Los Angeles .... full details will be on searchforacure.org
http://www.searchforacure.org/
What is detailed in these 'updates' should be interesting. Maybe we will see a company press release before hand?
Appears Mr Van Ness owns over $2 mil shares of CYDY ... this is from 2010 so I'm sure he's accumulated more since:
http://biz.yahoo.com/t/90/8319.html
Here's the agreement:
"During the term of the Trading Plan, Greenwood may sell no more than the lower of (i) 148,500 shares of the Company’s common stock, or (ii) $375,000 in value of shares of the Company’s common stock, subject to the terms and conditions of the Trading Plan. Sales of shares of the Company’s common stock under the Trading Plan will commence no earlier than March 14, 2012, and the Trading Plan will terminate on September 12, 2012. The shares of the Company’s common stock may be sold whenever the Company’s common stock reaches specified market prices, and neither Greenwood nor Mr. Van Ness may influence how, when, or whether to effect sales under the Trading Plan.
Greenwood entered into the Trading Plan so that Mr. Van Ness can repay certain of his personal debt obligations."
Breakdown = at today's closing price of $2.80, he can sell 134,000 shares over six months begining 3/14 - probably less than 5% of his holdings ....
My take = doesn't speak of someone bailing rather someone looking to capitalize on an upswing with following potential March news releases (that I'm aware of):
-- Dr Elder reporting on FIV
-- Dr Rosenberg reporting on mechanism of Cytolin
-- Publishing of January 2012 meeting where the Theurapeutic Potential of Antibodies for HIV was discussed and included:
Dr. Richard Trauger
Managing Director of Science, CytoDyn Inc.
http://searchforacure.org/index.php?option=com_k2&view=item&id=46:a-meeting-regarding-the-therapeutic-potential-of-antibodies-for-hiv&Itemid=123
Exciting times for us CYDY holders imo!
Potential Huge Payday for CYDY
shallwemaui -
Just flesh and blood like you trying to make a few bucks ....
Check out this article where $11 Billion was paid for Hep C drug. With only 25 mil CYDY shares that'd be a HUGE payday!
http://www.bloomberg.com/news/2011-11-21/gilead-to-acquire-pharmasset-for-11-billion-to-add-hepatitis-c-medicines.html
*** Why to be Optimistic about CYDY ***
Links will get you up to speed and help you understand our Optimism:
Latest financial blog on CYDY
http://community.nasdaq.com/News/2012-02/cydy-promising-antibody-technology-for-the-treatment-of-hivfiv-analyst-blog.aspx?storyid=121000
Interview with Dr Rosenberg at Massachusetts General Hospital. He agreed to study this antibody in his laboratory to determine its mechanism of action
http://searchforacure.org/index.php?option=com_k2&view=item&id=35:cytolin-a-monoclonal-antibody-therapy-for-hiv?&Itemid=146
CytoDyn Enters into Research Funding and Option Agreement With The Scripps Research Institute for FIV treatment (Feline HIV/AIDS):
http://www.businesswire.com/news/home/20111116006785/en/CytoDyn-Enters-Research-Funding-Option-Agreement-Scripps
Newsletter Proclaiming CYDY it's 2012 Penny Stock Pick of the Year
http://stocknewsalerts.net/newsletter/look-2012-penny-stock-pick-year
You tube videos and news reports of Cytolin: