Fred, let me get this right. You have zero investment in CYDY. Your posts reflect a rather bearish scenario. You are very concerned about Posts that are of the opinion that Pro-140 may be worth billions is misleading investors. My personal opinion is if all goes as planned we are looking at $5-$7 per share buyout within the next 12 months. That is my opinion based on my conversations with management. You and Pears present yourself as experts (with basically no skin in the game) as watch dogs for the naive investor that is looking at investing based on the dialogue on this board. Who are you to say you know best? Misiu is not some uninformed investor that is trying to convince anybody to load up based on her opinion. You on the other hand seem hell bent on pounding your bearish opinions relentlessly on this board. By all means state your opinions backed with zero investment - they match up perfectly

My take is they want to insure they have enough $ to make it to the milestones that have the potential to move the SP. it will be interesting to see how quickly they are able to fill this offering. I'm sure Paulson is pitching a story line with a very strong emphasis on upcoming milestones. Investors can sign an NDA and get the inside scoop.

There isn't any ambiguity. Just shedding some light.

Technically the FDA has 60 days to meet after receiving the request and that is where the Oct. 17 date came from. A standard response. The company is not settling for that date and consequently doing what they can to convince the FDA to move the date up. Because of the nature and circumstances of this meeting It would seem quite possible that they can secure an earlier date. This is the FDA so who knows. So yes we are in a news vacuum until this meeting takes place.

Yes, SP will drift and create opportunity. I'm loaded and not concerned with low volume moves. This story is going to hit major volume either based on positive or negative news. I'm betting big on positive news.

They have to anticipate an additional 4 weeks lag time to produce Combo PE data from Oct. 17 meeting with FDA unless the meeting can be moved up. That puts us into Nov. Dec. 15 million to get to milestones. Then the big raise to insure getting to the goal line if the buy out price is less than satisfactory.

Read 16919.

Offering started last week and is subscribing.

My best guess is Mono enrollment will be right at 200 by the middle of October. I know they are not having any difficulty enrolling unlike the Combo Trial. The Paulson raise will give them the needed $ to open more sites and hopefully hit 300 by years end.

As for BLA. I believe they will get approval to submit their BLA this year from the FDA. Putting that application together and submitting will takes us into 2018. The important thing here is once the FDA gives their approval to submit it is a mechanical event. Approval to submit by the FDA adds tremendous value to Pro-140 because it means the drug has a pathway to commercialization. If BLA is approved along with the blessing of AA and BTD by the FDA the likelihood of an Organic uplist is quite probable. This is what the company is shooting for to avoid a R/S. they know they need multiple events to happen to get the pop. They also know making it to either the Nasdaq or NYSE will garner institutional investment and visibility. That is the pathway to the kind of valuation that many here are hoping for.

It's all about how the FDA views the PE data. That is why so much caution is being taken before locking the Combo Trial and unblinding. They will continue to enroll until the FDA concurs. The only issue the FDA can bring up is you need more patients because some of your patients don't meet the profile. Believe me this may sound over cautious but at this stage it is the right approach. Botching this up would be a serious set back. It's not a delay it's prudent business.

The locking and unblinding of the Combo Trial will not happen until they meet with the FDA to reach agreement that the patient population has satisfied the agreed upon protocol in reference to the patient profile. Because the trial is small they will not take a chance on a misstep on this critical aspect of the trial. They are pushing for a meeting with the FDA prior to the scheduled Oct. 17th meeting. They feel they have satisfied the protocol but because of the severe nature of these patients illness they are continuing to enroll. They are very confident that PE will be achieved but they need the FDA to agree they have the correct patient population. If this were a trial with 200 patients they would not ask for this meeting- 30 is a small number.

Because the future of Pro-140 and our investment hinges on the outcome of this trial to open the pathway for approval they are taking a very conservative route. IMHO the bottom line is Tony is not going to give the FDA any wiggle room...he wants confirmation.

To bridge the gap to the needed catalysts to hopefully generate an organic uplist they are raising $15 million through Paulson. Offering is .75 and 50% warrants at $1. This is currently being subscribed.

Catalysts:

Combo PE Data
The green light from the FDA to submit BLA
The grating of AA and BTD by FDA

As I have said before a sweep in the above catalysts would be a home run. The strength of the PE data along with safety data from Mono is going to determine BLA, AA, and BTD. If we have to wait until Oct. 17 for FDA meeting that will push us into November to compile and PR PE data. Then the all important meeting with the FDA to find out if they are going to help expedite approval.

Once again my trust is in Tony to cross t's and dot i's. This is why he is calling the shots. This is his area of experience and expertise that is critical.

Pears, not often have I been on the same page. Are you playing the bulls.

No, what I mean is he is seasoned at working with the FDA. Without him we might have unblinded when we shouldn't have. He has first hand experience moving through this delicate process, consequently I trust his decision making process.

Wooden bear, that is the question that we don't have an answer to that will complete the story. IMHO the study has not been unblinded and Tony C is cautious to insure alignment with FDA and not jump the gun. It appears that they are packing what was supposed to be in two meetings with the FDA into one on Oct. 17. This is where I seriously would have a hard time staying in without Tony's experience. He knows the FDA process well. This will be clarified at the annual meeting this week. Things are getting exciting.

The current meeting with the FDA is to gain assurance that they are on the same page with locking the trial. Then they will crunch the data and meet a second time. BLA, BTD, AA cannot be discussed until they have the compilation of the data. The Combo PE data and Mono data will be used to submit both the efficacy and safety packages to the FDA. The outcome will have a profound impact on Pro-140.

Will we be dashing ahead with BTD, AA, and a clear pathway for gaining BLA approval?

Or will the results of Combo PE be lackluster and non conclusive and the FDA asking for a broader based P3 trial.

I strongly doubt the later. Chances are good that we can get it all. The result also may fall somewhat in between like you met Combo PE and let's discuss BLA but no on BTD and AA. The results will need to be convincing on the Combo PE to get it all. The safety part of the package should be a slam dunk at that point because there have been zero SA's or safety issues with over 200 patients. This is important because safety is where they put the hammer down. The FDA approves many drugs that may not be significantly efficacious but they are very stringent when it comes to safety. That is another reason why I am so bullish on Pro-140. Its all there.

Fair enough Fred.

Thank you Gestalt. 100% on the money.

Fred is into his own speculation based on just that, speculation. If I saw things the way he did I wouldn't spend all my time posting on this board. I would watch and wait instead of aggressively defending and posturing opinions.

My understanding is this upcoming meeting with the FDA is about locking the Combo Trial so they can unblind and crunch the data. Then 3-4 weeks later PR and submit the data for Combo PE and safety data from Mono. The FDA will decide if Combo PE was achieved for efficacy and then review both trials to determine safety. Those are two packages that the FDA will review that will influence the approval for BLA submission, and the granting of AA and or BTD.

As for raising $ my understanding is they have enough with the last 6 million convertible note to get through the pivotal FDA meeting that determines the speed at which Pro-140 will be approved.

They were not planning on PR'ing completion of enrollment but I think they changed their mind because;

The size of the trial is small with 30 patients. Tony is concerned that if they lock without the FDA's consent the trial could be compromised if they missed something. He is being ultra cautious because there is so much riding on the Combo PE data. They are not trying to change or adjust the protocol. IMO Fred is way off base with his speculation. They are not hiding some bad news...that's BS. They are taking a longer path but one that eliminates risk.

So, because they decided to wait for the FDA meeting to lock they knew it would make everyone highly nervous if they waited until late September to PR Combo PE data. People would speculate they were unable to complete enrollment without a PR. That's why they PR'd 33 patients enrolled.

We can't control the data but the company firmly believes because of prior clinical trials both Combo PE and Mono Data will be strong enough to gain BLA approval. There has been absolutely no SE's as safety is squeaky clean. Tony has been down this road many times at the highest level with Gilead...do you think we are in good hands? I think they believe they have a very strong opportunity to raise at $2 after Combo PE Data is released and meeting with FDA to discuss BLA, BTD, and AA. That puts us into late September early October.

The 15 million raise petered out so they closed it. At this point Paulson is rumor. I know they don't want to raise at .75. They are waiting for PR on Combo PE. They are confidant they can raise at a higher price. Looking at Oct. for a bigger raise. How big depends on SP.

Many good posts today. They are not taking any chances with a trial this small to lock until FDA is in agreement. Technically the FDA has 60 days from the time they requested to respond. I'm not trying to scare anybody into 60 days as the company feels they should have a decision any day. Vacation time doesn't help with speeding up an already slow moving FDA.

If PE is achieved in the eyes of the FDA and AA and or BTD is granted we will be on our way to a buyout. Enroll Mono By the end of this year and let the interested parties sign an NDA and take a peek. As Tony said the empirical data will dictate our future. They do not anticipate having to complete the Mono Trial to sell this company.

Many speculate at to what the SP would garner in a buyout. My sources tell me the company is not willing to take $4 but would take $10. So logic says somewhere in between. Obviously the further we go with strong data the higher the price goes.

I agree on all fronts.

-they are not concerned with raising $.
-the science will not be sold in pieces.

-they expect to be purchased however I think it may take a little longer than 6 months, 12 months max.

-up listing becomes more of a priority if we cannot find a suitor.

-strength of data and FDA will determine our fate.

-people don't believe they will fully enroll Mono Trial by end of year. They will most likely complete enrollment by November IMO. Tony is very confident of this if they could get the Combo enrollment completed. Now they can poor all their resources into Mono.

We are in a waiting game until the FDA decides our fate. I mean they can expedite this or drag us through the mud.

The Combo Trial crossed 30 patients some time around mid July and now we have 33. My question now is have they reached agreement with the FDA to lock the Trial so they can unblind and see the all important PE Data? There is nothing in the PR that validates this other than they look forward to releasing results in the coming weeks.

As Tony has said it's all about the data. Until PE is released here we will sit in terms of SP. It's really should be no surprise to anyone that the SP remained flat. It's a non event in terms of the efficacy of Pro-140.

IMHO our fate is controlled by the data and the All Mighty FDA. Much will be decided in the next couple of months with PE Data, safety data, and the all important meeting with the FDA to discuss BTD, expanding label for Mono, and BLA pathway. I really believe we have a legitimate chance to run the table because the data will be strong...convincing enough for the FDA? We shall see.

Wow, you shock me sometimes.

Fred, I do not follow all the raises. This was one of many and was the first I got in on. I wouldn't base your math on my last post.

I have three sets of warrants. The oldest expire in October 2018. That was a raise that was oversubscribed at .65 and 50% warrants at .75. I believe there was approximately 7.5 million warrants on that raise.

Tony, your share count is accurate. Also agree with your risk assessment. Thx for your opinion.

Another post that is right on the money Fred. That is a major item on the list with the next meeting with the FDA. Question is how strong is the data and will there be enough of it to get the FDA to grant BTD and broaden the label. That's the game changer right there.

Fred, you make many very valid points and you are a clear, logical thinker. I stay as close to the real story as possible because I have a lot of skin in the game relative to my portfolio considering the high risk of this investment. That's about as much as I can say and people can choose to believe what they want.

IMO-Much of what is posted here is logical speculation. On the other hand it is clear that many are way off track in terms of managements strategy and thinking. It is difficult to read posts that get further and further away from the reality of what is actually in the works.

IMO-There is a lot of investor fatigue and for good reason as delays have hurt SP and tested investor confidence. That fatigue leads to fear. To alleviate fear fresh news is the anecdote.

IMO-The reality is the company is not concerned with the micro picture and they are not making moves to comfort shareholders in the short run. They don't want to water down the PR on PE data. They also don't want to be tied to a timeline by PR'ing enrollment completion which is complicated in its own right. They believe the only thing that will create momentum is data which is a black and white event. As Tony has said the empirical data will dictate Pro-140's fate. I have argued in favor of the enrollment completion PR being a significant event that would calm the waters and instill confidence. They don't see enough value in making that announcement. Tony and his team are fully informed and have access to all the details. Tony also has experience at the highest level both in manufacturing, bringing drugs to market, the FDA process, and HIV space. Is he more qualified to make the call here or are we?

I'm invested in two things here. The science and Tony's ability to get the trials completed and get this company sold. I believe in both.

You are spot on BD.

Thanks for reminding me about the disclaimer KobeF.

ALL IMHO of course.

Grip, you've lost perspective. The only thing that has possibly changed is not getting a PR that Combo enrollment has been completed. I've been saying for nearly a month the company has no intention of PRing completion as they view it as a non event. Being that it takes 4 weeks to compile data after they lock the Combo Trial, we are looking at PE Data being PR'd just prior to the CC on the 25th. Trust me the Trial is locked and they are compiling. Go play some golf and readjust the reality of when the news will be released. This is the way this investment works.

Why would CYDY sell before the pipeline is more mature?

They won't unless the price is right. I think $6-$7 is the bottom consideration right now.

They are hoping to expand the Combo label in September with the FDA by presenting the safety data with the Mono Trial. We should be at least 50% enrolled by September meaning 150 patients. They understand patient population has everything to do with valuation in reference to a buy out.

Your right we have no reason to think the results will be bad.

Back in January they had 7 patients that had completed the Combo trial and opted for rollover/extension study. I'm thinking we will have 75% or more that continue on extension. This Combo was a bitch to fill but a slam dunk in terms of safety and efficacy even with the sickest patients. They relaxed the PE criteria by 40% from viral load reduction of .07log to viral load .05log.

I'm not concerned about PE results. The million $ question is "will the safety and efficacy package they submit to the FDA in September be enough to satisfy the granting of BTD and a clear pathway for submitting the BLA". The FDA will have a big say in how fast we are able to proceed this year. IMO the granting of BTD would make approval not only eminent but give us AA and a much faster approval process. That means a buy out comes sooner than later because the Mono Trial will be lining up perfectly for a potential expanding of the label. My guess is the market and BP will take notice if we can get the nod from the FDA. This will be our shot at an organic up-list.

As for the convertible note, it was the best option for financing at the time because of the depressed SP. It was also a great deal for Tony C and others that ponied up. Making a BK play IMO was not part of their thinking. Their bet is they will be converting to stock that will far surpass a .75 SP this year.

Stated well BH. I was going to reply and set the record straight. Glad you did. A very misleading post. The company is not running scared wondering how they are going to raise $'s. They will however raise with the best terms.

Company is committed to getting Combo PE data out prior to meeting Aug. 25. Compilation of data takes four weeks.

This to me means they just completed dotting the i's and crossing the t's with the FDA so they could lock the Trial and unblind. My guess is they now know the results are very positive meaning much more favorable environment to raise $'s.

Management has NO intention of bringing Pro-140 to market. They are going to take the best offer in the next 12 months. Data just needs to continue to validate efficacy and safety.

The FDA approves many drugs with less than strong efficacy. They don't want to look stupid approving a drug that is not safe. Pro-140 has NO signs of safety issues and that is a big leg up.

Hopefully the first 100 in the Mono Trial will more than satisfy safety side of the package.

Management would not move ahead with a R/S unless future positive PR's were in the pipeline to support this type of move. Professionals like Tony have been around the block. The thinking is they have to open this up to institutions but they are not going to jump into a R/S praying for a hail marry.

I do not like the idea of a R/S however if we can't get there organically it may make sense by the end of the year to take the gamble. If the Mono Trial is filled and we have some momentum the timing may be right. The point is they are not going to back into a R/S without momentum and positive news on the horizon. They know the SP will get killed if not supported with solid news. I know they would prefer up-listing to the NASDAQ. That's $4 minimum SP. I could see us at a $1.5 and doing a 4:1 split. They may opt for the NYSE which is $2 SP and do a 2:1 split.

I am really hoping this can be avoided and I understand cons far outweigh the pros. History supports that. As BD stated so clearly in some cases a R/S can be a powerful tool if used in the right circumstances. This may be a fit. I just can't take that tool out of Tony's hands.

I would prefer Combo enrollment completion to be PR'd, however at this moment that is not the plan. Next PR will be Combo PE results and it will come prior to Aug. 25 meeting.

IMHO.