I was too. Like I said I think they are going ultra conservative on timelines. I think we will get a PR much sooner than the 4-6 weeks.

It appears that meeting Combo PE should be a slam dunk. With 11 completing the full 24 weeks and 10 of those on extension it appears Pro-140 is working well.

I believe the timelines announced are conservative to insure they are met rather than missed. I would think we will have interim PE prior to the projected 4-6 weeks. Beating expected timelines would be a positive and have a bigger impact on the SP.

GVHD looks quite promising and could be a real sleeper in terms of attracting a partner.

Big unknown is what impact interim PE will have on SP. That is obviously the next big event.

You nailed it Bobby. The six employees is misleading.

They hired two KOL’s for the FDA meeting to explain the absolute need to relax requirements, experts that speak the FDA language. They got the job done. What many don’t understand is how proficient Tony is at accessing his resources to bring in expertise when needed. Because the company is not taking Pro-140 to market they are much better served to stay lean and outsource. There are so many details that we the investor are not privy to and management is not going to take the time to explain it all.

Obviously todays CC is the opportunity to get the facts, ask questions, and then reassess. I’m sure there will be those that come away with a more secure and optimistic outlook of Pro-140’s future, some neutral, and some that remain negative. The only thing that really matters to me is to stay informed and current so that my expectations are realistic.

Yes, the 300 patients for Safety will be clarified on the CC.

As for saying this was a regular FDA meeting that is false. I always said the purpose of the meeting was alignment and agreement with the FDA on the profile of the patients enrolled in the Combo Trial. The company knew there was an issue here which is why they continued to enroll. I stated many times this was the focus of the meeting.

As for being optimistic about the FDA meeting I believe the meeting was a success and my optimism remains unchanged.

Seems to me that the FDA meeting was a success not a failure. Bottom line is PE will be achieved with both interim and N=50 and we will have interim confirmation before the end of the month. They were always going to need 300-500 patients for safety. Now they know the number is 300. I suspect we are close to that number right now when including all previous trials. I know they have to complete 24 weeks but that has always been the case.

From my perspective Pro-140 is on the verge of being significantly derisked. The company knows they have a drug that is safe and efficacious and like a dog with a bone they are not going to give it up cheaply. Working with the FDA is part of the landscape. Tony and his team are focused on execution not the short term SP.

The question is what impact will interim PE have on the SP? Will the interim PE data make the complete enrollment PE data of 50 patients a non event because it will be clear that achieving PE is a done deal?

The cost of raising money seems to be the major question. Not if they will be able to raise money, and not if they will be able to complete the trials.

My bullish perspective remains unchanged because I believe Tony has the experience to execute the steps necessary to get this compound into a desirable and valuable position to be acquired. I also believe the value of Combo approval alone is much greater than many here believe. The prospects of a much expanded label is also a very real possibility. In addition GVHD adds value.

It seems there are but a few that dominate this board with a bearish perspective. That is not the consensus of the major investors in PRO-140. This stock trades just North of 100k shares daily. That means everybody is holding except the day traders trying to make a buck.

I'm sure we will learn more on the conference call tomorrow however it is our responsibility to ask intelligent questions that reveal the details.

My understanding is a decision would be rendered one way or another today. This wasn't a let's consider everything and get back to you meeting. Having said that the FDA may not see it that way. IMO I think we will wake up to a PR.

That's my thinking.

11am EST

Once again BD stating it oh so clearly.

There is a very strong possibility that the news is a green light from the FDA. The worst case is they need additional patients because not all meet the FDA's criteria. Again that is why enrollment continued and they have IMO well over 40 to satisfy the 30 required.

This investment hinges on getting this trial locked so they can PR the Combo PE data. If it's positive we have a clear pathway to the BLA process and Pro-140 will be viewed as a drug that will make it to market in some type of label.

That would create a much different landscape in terms of raising $ and also derisked to a level that could garner attention from BP as a buyout.

We will get there one way or another. As most understand a green light from the FDA is going to mean faster and less penal so yes there is much riding on the outcome tomorrow.

A17,
You have to admit you have a negative slant in your posts relating to what you call the facts. Fact is you don't appear to be very optimistic about the future of Pro-140 and the team that is guiding the ship. You have quite a following on IHUB so one has to wonder with so little skin in the game what your agenda is.

I hear ya. A big load lifted if the FDA agrees to Lock the trial. I expect a PR when we wake up Friday morning. The SP will tell the story without even reading the PR.

IMO this meeting is about being in agreement with the individual patient profile and the agreed upon protocol. I believe there is some gray area that is in question. That is why they continued to enroll additional patients to replace any the FDA may deem unacceptable.

ALL IMHO.

I think we have to remember Thursdays FDA meeting is to get confirmation that the trial can be locked and PE can be determined and results released in three weeks. Maybe we get a nice uptick with good news on Thursday and the big move if /when PE is PR'd. To me the real news is meeting PE. But obviously we need agreement from the FDA on Thursday to get to PE.

Thanks Grip, just calling it the way I see it. All IMO. Thursday is big.

As usual spot on BD. I like the way you think, feel like you read my mind. Keep up the concise articulate posting.

Grip, I agree with the granting the power for the company to R/S. BD and others here stated the situation clearly in their posts, we have to give the company the power, period.

It appears most here, at least those that posted this morning are seeing the same logic.

If we can get the green light from the FDA on the 12th we could really see some momentum consequently we have to empower the company to maximize the opportunity.

Well said BD. Logic says GVHD enrollment rate should increase moving forward. I think year end may be a bit aggressive but who knows; well that would be a question for Dr. Berger.

Another iron in the fire certainly increases valuation especially with ODD. Success with GVHD may also open additional opportunity in the cancer space.

As stated this news also makes for a positive backdrop for a possible momentum run with all that is in front of us the next 4 weeks. It could very well be that the pathway to a R/S makes sense if given a green light on the 12th by the FDA to Lock and unblind the P3 Combo and then the all important results to follow three weeks later.

What will the SP be if all were to go our way? If we could approach $2 a low ratio R/S could make sense with both P3 Mono and P2 GVHD moving forward.

ALL IMO

ODD may speed up the process. Don't quote me on the number-maybe more.

This is Dr. Berger's baby and he has a successful resume. He has been very enthusiastic about GVHD and the results. As everyone knows it is a small patient population but that's why they were granted ODD along with efficacy and safety. I believe the current P2 calls for 60 patients and I dare say IMO we may be approaching 10 patients enrolled.

Ok, let's get precise,

"They should have 42 patients enrolled giving them 12 extra to take the place of any the FDA may deem unacceptable.”

That is my projected number. I hope Broker is right and we have 47.

42 is my projected number by October 12 given the enrollment pace. As Broker said he has heard 47. I hope he is right. It is no secret the company continues enrollment as a top priority until the FDA agrees to Lock and unblind.

All in my opinion. Not an employee obviously. Continuing enrollment is a given. The more the better.

Truth is they have an open raise with Paulson right now. Problem is it's at 75 cents and $1 warrants. That isn't getting overwhelming attention with the current 60 cent SP. I think they have raised about $2.5 million on a $15 million offering.

Management is thinking green light from FDA Oct. 12 and a PR three weeks later with positive Combo PE results will change the environment for raising $. They have 42 patients enrolled giving them 12 extra to take the place of any the FDA may deem unacceptable.

Yes this is a gamble but a forced gamble. They know they will have to lower the bar in terms of raising $ if the FDA drags this out time wise with more demands. All I can tell you is they have submitted both efficacy and safety packages to the FDA for review prior to the meeting and have two KOL's that work with the FDA in the HIV space presenting the facts on behalf of Pro-140. They are prepared and very confident but this is the FDA.

To me this is where the rubber hits the road with these two events.

While I would much prefer avoiding a R/S it is a logical option the company must have the power to initiate.

Management is not going to R/S unless they get a green light to Lock and Unblind by the FDA on Oct. 12 followed by a PR three weeks later confirming Combo PE was a success. After those two events it's all about where the SP is. Will we get a bump to $1.50 or higher, or lower - nobody knows. Regardless, IMO this is where the R/S is going to be timed. They will split with a ratio to get to $6. This allows for a $2 cushion to stay above $4 on the Nasdaq. Meanwhile the boxes will be getting checked as they work through BLA. The P3 Mono will be filling enrollment and Tony will be pushing the fact that Pro-140 is going to make it to market at the very least as a Combo option with the increasing possibility of Mono therapy approval.

On the other hand if the FDA gives a yellow light on the 12th and wants more patients that's going to change everything and create a much more costly environment to raise $'s because the SP is going to drop. I really don't want to think about that possibility but this is the FDA. It won't sink the ship but it will be costly if it means much of a delay.

Consequently, IMO the most important events are not the likelihood of a R/S but the outcome of the Oct. FDA meeting and then the results of the Combo Trial which will determine the momentum and immediate outlook for Pro-140.

In addition I don't understand what Tony should be doing differently to effectively get Pro-140 into a buy out position. He can't control the FDA or the SP. All he can do is navigate the approval process- something he understands quite well. He also understands the HIV space and what it's going to take to get this company sold.

I would love to be a fly on the wall at the Oct. 12 meeting. Guess we will have to wait until the PR on the 13th. The SP that Friday morning will tell the story. Even with a green light from the FDA I don't expect much upward SP movement because the real news is the Combo PE data which would come three weeks later.

GLTA

Lawyer, you state it simply as is. Tony and his team are much more informed and calculating then anyone on this board. They are only going to roll the dice if the R/S can be supported. I'm really hoping this FDA meeting can turn the momentum in Pro-140's direction. We are so close, but yet as usual at the discretion of the FDA. Oct. 12 can't come soon enough.

The R/S is an option. Nothing has been decided other than a vote to increase authorization to R/S from 10:1 to 15:1. It seems many here now think it is a foregone conclusion that a split will take place. That is not the case.

Tony knows they have to get off the OTC if they are going to attract institutional investment. The first option is to get an organic uplift in SP through positive PR's in the form of favorable data from the Combo Trial and Safety data from the Mono Trial. They are hopeful that will lead to a BLA approval from the FDA. If BTD were granted in addition that could provide the horsepower for an organic increase in SP needed to avoid a R/S.

Another option on the table is a R/S somewhere in between these events as there would be positive news in the pipeline to support the split. One thing is for sure they will not R/S without positive news in the wings to support a R/S as they know the shirting that would occur.

Obviously there are many moving parts. The first of which is the meeting with the FDA. We absolutely need agreement to Lock and unblind to get to the results.

Here we find ourselves in the all to familiar waiting game. The challenge is to stay focused on the reality of the current position of this investment.

Well stated BD. This is not speculation, it is a fact. The opinion that the company knows the data is weak so they continue to enroll is simply untrue. This is ALL about the FDA reaching agreement with Cytodyne regarding the patient profile of the individual patients in this trial. That is why they are continuing to enroll. If some are not accepted they have an extra 10 that can qualify.

NO, Management cannot see the data.

They are confident in the efficacy and safety of Pro-140 for two reasons.

The results of all previous studies produced viral load levels that were much lower than the viral load needed to meet PE in the current Combo Trial. I have spoke with the company several times concerning meeting Combo PE and expectations relating to the P3 Mono. Their expectations are considerably higher than just squeaking by the viral load requirements needed to meet PE in the Combo Trial. As for the P3 Mono I mentioned a 50% success rate in terms of successfully suppressing viral load for one year would be great. The response is they expect much better results. With no safety issues up to this point they are very confident on both efficacy and safety. Their concern is straight forward - are they in agreement with the FDA regarding the profile of the now close to 40 patients that have been enrolled in the Combo Trial. That is the only reason for the upcoming meeting with the FDA. Agreement so the trial can be locked and unblinded so we can get on with getting Pro-140 approved.

This will change when PE and Safety data validates a BLA. That will signal the type of proof needed to substantially derisk Pro-140. The street wants the proof. Up to this point we are viewed as just another Biotech penny stock with a hopeful drug.

Your Welcome.

Gestalt-two very good Posts.

The bottom line is as you said just because it's taking a little longer lets not lower our expectations.

I firmly believe we are bought out next year between $5-$7 long before the completion of the P3 Mono in light of all the numbers you referenced.

Thanks for doing the homework.

I agree with you on all points BD. However I think you mean the trial is still ongoing meaning the trial has yet to be locked. That is the nature of the upcoming Meeting...FDA agreement to Lock the trial and unblind so the data can be compiled and revealed.

You are absolutely correct no one has access to the data at this moment. There is nothing to indicate a problem with meeting PE. This IMO is not something the company is concerned with.

This boils down to one decision by the FDA- do the patients fit the agreed upon protocol. Cytodyne has submitted their package to the FDA demonstrating they have. Their KOL's will do everything in their power to prove they have on Oct. 12.

Fred, If all goes well with FDA meeting the time to buy is now or prior to meeting.

Your scenario is the plan and it is dependent on:

Agreement by FDA to Lock and unblind study Oct. 12

Convincing PE and safety data PR first week in November

Organic rise in SP, and then hopefully a low ratio R/S to uplist to NASDAQ.

Then all eyes on BLA and Mono Trial.

IMO if this goes as planned buy out will happen before Mono P3 is completed because Pro-140 will be derisked to a palatable level for BP to move.

GVHD will be thrown in as an added bonus.

That is my understanding of managements plan.

They are speaking on behalf of Pro-140 at the FDA meeting on the 12th. Management isn't going to have much to say-their KOL's will so it will stand to reason they are there to speak in favor of Pro-140. The FDA has their own KOL's in the form of the 12 HIV know it all's that will be represented across the table from the Cytodyne team. As we all know this is high stakes when trying to get a foot in the door to a 15 Billion $ plus market.

IMO the outcome will be a go not a no. The company is thinking it will be a go also because their KOL's feel the same way. The wild card is the FDA. If the FDA were to delay this trial because of a technicality relating to the patient profile it would be nothing short of collusion considering how complicated the patients profile is. Because Tony has chosen to continue enrolling until the FDA gives its approval everybody is assuming something is wrong. Nothing is wrong. It's what is prudent; Tony deciding to take the safe route rather than Lock and unblind the trial based on the company's perspective without FDA consenting. This is a precaution that is perceived as a delay and a changing of the protocol by the company. That is not the case. This is a clear example of Tony's experience. I am very bullish but waiting on the FDA to decide makes EVERYBODY nervous.

The upcoming meeting with the FDA is to qualify the patients to make sure the FDA is in agreement that the protocol has been satisfied. That is why they are continuing to enroll and plan to have 40 patients by Oct. 12. Management along with their KOL's believe they have satisfied this requirement but they are not willing to lock and unblind the trial without the green light from the FDA.

As stated by Gestalt they are quite prepared for this meeting and more than confident with their team of KOL's. They are not worried about the PE data as they know Pro-140 is both efficacious and safe. They are just as upset as we the investors are that we are in a holding pattern waiting on the FDA's graces to agree with the patient profile. It costs money and creates a vacuum with no news in the interim to support the SP. The difficulty and complexity of the patient they need for this trial is ridiculous and the FDA knows it. That is why the trial was reduced from 300 to 150 to 30. Management would never have agreed to this trial were it not for a requirement by the FDA to be allowed to move forward and be considered as a Mono therapy.

It is unfortunate the Combo Trial has slowed the approval process to a snails pace, however the Mono Trial is a cake walk by comparison as they have already enrolled over 150 patients because the patient population is easily identifiable and straight forward to qualify.

IMO the next press release will be Oct. 12-13 that will either be a go or a no on Locking and unblinding the Combo Trial. If it's a go they will ramp up to compile and release data within three weeks. That will be the closing of one long chapter and the beginning of the last chapter which is the real potential of Pro-140 as a single agent solution and a threat to SOC leading to a buy out.

If it's a no then it will be delays that will cost us dearly in the form of dilution at a hefty price and a stronger possibility of a R/S. What I do know is, regardless Tony and his team will raise the capital needed to get Pro-140 to the finish line. They know they have a drug that works and is safe.

BD, your post summarizes precisely where we are and why we are here. Tony could have jumped the gun and compromised the entire Combo trial. Instead enrollment will continue until the items in question meet the FDA's requirements. The good news is there is nothing negative concerning efficacy and safety. I will say my patience is being tested as we wait for this trial to be locked and unblinded.

As for sources I will not give up my sources, if I did they would no longer be a source.

I think you answered your own question.

"I can see where the FDA might consider the combo PE data in conjunction with the mono safety data to grant the BTD and perhaps lay out a clearer path to approval than we have now."

As stated several times the Combo Trial PE Data is being used to create a pathway for Mono with the FDA. The FDA all but told CYDY to supply PE Data for Combo and additional safety data from the Mono Trial and if results are strong we will consider Pro-140 as a Mono therapy.

Tony and his team believe Pro-140 has the goods to ultimately be approved as a single agent, however they plan on being sold long before approval. If efficacy from Combo PE is achieved and additional safety data from the Mono Trial is clean the tipping point for a buyout will be primed to happen well ahead of the completion of the P3 Mono Trial.

As he has said many times the science and empirical data will dictate our fate. Up to this point only a few posters dispute the science. I trust Tony's judgement much more than anyone on this board. This is his backyard. Unless we hit a negative with efficacy or safety Pro-140 is going to disrupt SOC at some level. This is not a company that is going to zero like Wallstreet posted earlier. The only question is how much will Pro-140 fetch and when will it happen--that is the debate.

Welcome.