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My biggest regret is I bought SIRI at .08 cents when it crashed...sold it for .38 cents...Now it is 4.75..Ouch!! We may be faced with the same decisions on CYDY...that is why I want a huge "wake up to gap up"...No teasing up and down for several months/years! Put a Fork in it and get the heck out!
Just Give Me .15 cents on good data and I will be out of here. Come on Ohio State, El Camino and Stanford...release the data!
But But Shane...You'll miss out on the 20 to 50 run! Come on, man up and raise your GTC...go for the gusto my friend!
That is one good thing about an Over Head OF N=5 COMPANY.....Low Expenditures! You just pray they are the right 5 to bring all the upcoming catalysts to fruition!
This explains why GvHD has not been initiated. Nader and gang are trying to get BTD and Adjunct primary EP with minimal dilution. If GvHD were to be initiated, they would need a lot more capital to run two P3's and start a N=60 Autoimmune trial.. Perhaps waiting for Partnership, NIH grant or BO to keep the share count at a minimum. Besides..GvHD is years out and Adjunct is less than a year..Hopefully!
You were teasing the beggars. Like 20 of them! When you get overly zealous without substantial backing..what do yo expect!!
So Would I! And Mant other Developments..2017 the GOLDEN YEAR!! Beloved..Pearsby!!
Thank you for the respectful reply. Believe me, I am in heavy and and routing for you!! :>))
That could very well be! GvHD was suppose tom be initiated in early January. I believe the Data on HIV via the BO proposition could be the hang up!
I am sorry if I am misunderstanding your post. You are talking about P2..we have two p3's! Perhaps I misinterpreted your post!
I respectfully totally agree. That is why today's appointment is a good start! I am still very disturbed that Institutional money is blocked out! I realize the pro's and con's of RS...but with some many catalysts on the horizon, I believe that will Shunt the shorts efforts!
Variable- up listing and $20+ Why I say this I have a broker that has clients waiting for it to get off OTC so SEC will allow his firm to purchase and has $3million in orders. I can imagine how many other brokers are in the same position.
JMHO
I hope 20 plus is doable..Believe me..retired city. There have \been other posts projecting 30 to 50 dollars pps! Please keep in mind, I hope you are correct..But also keep in mind Reality! When you talk about a pps of 20 to 50..think Market cap to keep things in proper perspective!!
I have NEVER bashed the Science. Just referenced a similar CCR5 MOA...which refers to potential similarities in efficacy, but still gives options to tolerance, convenience, compliance and resistance if Haart drug(s) loses efficacy! Respectfully..Pearsby
No problem. I have done my DD. I am not 100% sure Pro 140 will be granted BTD , ODD or hit the Adjunct Primary end points. I am not sure post Croi there will be additional NIH grants, Partnerships, BO rumors and additional roll overs with strong Mono interim safety data to support the adjunct BLA (along with efficacy). Nothing is ever for sure..But I have an Adjunct 70/30 approval probability. I am sure you have your own..fine! This board is to express various views, possibilities and probabilities. You do not have to become hostile if our perspectives differ! Respectfully, Pearsby
Today's appointment was a good corporate strategic move, but not a pps mover in any significant way! We need, Institutions involvement/participation , BTD, ODD and Powerful Adjunct Primary End Point data..followed by strong roll over continual participation. If Mono continually supplies the Adjunct safety BLA requirements..then Huge. We have Croi in a few weeks as well...so many catalysts within 45 days!
Respectfully, in an early post I stated it would be strange the FDA would intervene into Corporate strategy. Please read ALL my posts. I think this decision came from the BOD with Nader's consent. Good, Smart, Humble move as we enter Catalyst city. Please read my posts carefully...thank you!
Not sure what you are implying. All's i can say is he is CEO. Are you suggesting the BOD pushed this through with feedback from the FDA?
I have an order at 5.15...actually I hope in a way it does not fill. Something is certainly not right here...Very disturbing! Beloved..Pearsby
Good point, I forgot about that feature on this board. Every board is different. Thank you Cynmark24.
Hand Holding...Not Hand Hiding
That would be quite strange for the FDA to intervene into corporate strategy..but who knows. So far they seem to be hand Holding PRO 140 through the gauntlet of scrutiny...like going from 300 to 30 (N) for adjunct and getting Mono off to the races!
I did not post a "but" in my message. Please point it out. I thought it was a good appointment headed into a potential sea of catalysts. The more expertise and experience at the top, the better. Nader made a good and humble strategic move!
I think today's appointment was a good move by Nader. It is this area where he will need assistance moving forward through the catalysts. I would call this a smart and hUMBLE MOVE. KIND OF LIKE A HEAD COACH LETTING THE OFFENSIVE AND DEFENSIVE COORDINATORS CALL THE SHOTS AS THE HEAD COACH OVER SEES!...Oops..sorry for the caps!
I think the 2B GvHD trial is 60 patients. They were suppose to start this trial by now! Perhaps the BO agreement is based on BTD and Adjunct. The GvHD is a back up, for all that is worth!
Actually, Adjunct can bring in 1 billion...especially with 2 Gilead Haart drugs losing patent rights in 2018! Mono, if retaining efficacy and safety... 5 billion plus. Back to IV administration. Another market for High density CCR5 cells..Perhaps higher penetration and affinity to these stubborn cells...extension of market penetration..no pun intended!
Jb..absolutely agree. However, now that we have the new information on CCR5 density cells, IV may be more penetrable. I realize what you are saying. The resources and capital into various studies are limited, however, we already have a good foundation on IV..that came prior to SC. SC is obviously better for convenience and compliance which will obviously enhance efficacy! However, the stubborn high density ccr5 receptor cells may need high dose IV administration..just options for various patient situations. Not sure if SC X 4 days is better than IV PRO 140? Maybe the suitor can figure that one out post BO!
We need to have both delivery systems ready for market. IV can offer certain advantages over SC in certain situations! Lets cover the whole HIV disease state! If someone opts out of IV..fine, but lets give every patient all the options via PRO 140 has to offer!
Nevertheless, the s.c. dosage form is undergoing clinical study, and i.v. administration may be preferred in certain treatment settings.
Change..Why does everything have to travel through E-mail..can you share via this format? Thank you...8 year Holder!
Trding..it is absolutely correct. They hired this firm for more exposure as we are so far under the radar pre Croi. See below:
NEW YORK, NY / ACCESSWIRE / December 22, 2016 / CytoDyn Inc. (the "Company") (CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection and other diseases, announces that it has engaged the expertise of NetworkNewsWire ("NNW"), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions, news aggregation and syndication, and enhanced news release services. NNW's strategies help public and private organizations find their voice and build market visibility via social media and a rapidly expanding distribution network of well over 5,000 key syndication outlets.
"Maintaining strong communication with CytoDyn shareholders is highly important as we pursue regulatory approval of PRO 140, our leading monoclonal antibody for HIV infection," says Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. "As we focus on our ongoing Phase 3 clinical trial with PRO 140, NNW will work behind the scenes and use its vast network to keep existing and potential investors up-to-date on our progress."
As part of the Client-Partner relationship with CytoDyn, NNW will leverage its investor-based Brand Network of partners, various newsletters, social media channels, blogs, and other outreach tools to generate greater brand awareness for the Company.
"Though tremendously invaluable, communication strategies are an often overlooked aspect of business for many biotech and biopharma companies," states Sherri Franklin, director of Content Marketing for NNW. "CytoDyn, however, is taking a proactive approach in making sure the investment community is aware of its progress. We look forward to working with this exciting company as it addresses a significant global concern and advances its clinical development of monoclonal antibodies for treatment of HIV infection."
About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized
In the present study, the duration of antiviral activity increased somewhat as the i.v. dose was increased from 5 mg/kg to 10 mg/kg. However, neither i.v. dose would appear to support highly infrequent (e.g., monthly) administration, and Emax analysis indicated that further increases in i.v. dose would result in incremental increases in antiviral effects. In a study of s.c. PRO 140, significant antiviral effects were observed when the drug was administered weekly or every other week, and virologic suppression was maintained between successive doses (7). While both i.v. and s.c. dosage forms have demonstrated favorable antiviral and tolerability profiles, s.c. PRO 140 was selected for further development on the basis of its potential to be self-administered by patients. Self-administration may offer greater convenience for many patients. Nevertheless, the s.c. dosage form is undergoing clinical study, and i.v. administration may be preferred in certain treatment settings.
I believe it may be due to the new PR firm that CYDY has hired for more exposure. I believe the new firm is trying to increase exposure, even with older data that they want circulated going into CROI. I really Believe the new Hired PR firm resurfaced this article. Nothing wrong with that, it certainly is relevant! JMHO!
Thank you Amature for your respectful reply with very good information. The Pharmacodynamics and Pharmacokinetics (T-Max, C-Max and half life are very different IV vs SC. However, that certainly does not diminish the potential of Pro 140 SC. All I am trying to respectfully convey is IV and SC are two different animals..as I am sure you already know. What I would like to see is an option for patients with more study. Maybe IV could be administered Once per month at a higher dose. I think SC at once weekly is the longest duration for VL suppression. In fact, they are talking with a higher density of CCR5 receptors going towards every 4 days...either way that's better than ever day with 4 pills and toxicity and AE's. I realize SC is night and day more convenient than IV, however, It would be interesting to see if IV once per month is equivalent to SC once per week...May be worth the trade off, especially if efficacy and AE's win out with IV. If they are both effective, the patient could choose SC vs. IV based on new data and the pro's and cons. For now, lets hope SC does the job at once per week in Adjunct and receives BTD and eventual approval!
The only thing I don't like about this article are three fold...1) It's out dated , 2) and most importantly this was IV delivered not Sub Cutaneous and relative dosing is different.
I agree! Let's all win together!!
Yes, 30 is better than 300! However, there is a statistical significant threshold that needs to be met! Not Charlie is doing great!
No Problem WS! I kind of went off the deep end with the 100% EFFICACY POST..AND YES THE CHARLIE S. N=1 POST. I am very Objective and hate the 100% or anecdotal posts...that is just my scientific background and not an emotional play..sorry!
That is the first thing from you that I agree with..Market invisibility!
.71 cents!!! That sure is a tell Tale of Market confidence within weeks of pending P3 data!....Pathetic and Sad. Nadar off the Radar..if the data is Favored!!
Nice try with the N=1 anecdotal/case study Report!! That is why the FDA requires Large scale, Double Blind, Multi centered, Placebo controlled trials for POC and Validation...not a Charlie Sheen Celebratory trial of N = 1...Seriously..are you that inept as to the scientific cause and effect POC!! Perhaps you should move on to other less technical stocks!!
NICE TRY 5Stop! If you think Anything in life is a 100%, THAN YOU HAVE BEEN LIVING IN DYSNEY WORLD! I hope your 100% probabilities come true!