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.
Nobody that has been on this board paying attention should be shocked by the decision to R/S and uplist to Nasdaq. This has been in the cards for the last six months. This is not a head fake. This is the only option at this point in the game and not a play to save the company from BK but to maximize exposure.
The strategy was to see if meeting PE could possibly move the SP organically to avoid R/S. If not no more positive news would be wasted on the OTC. If you were Tony what would you do? Continue pitching to a small audience or open the flood gates to an audience that can participate on the Nasdaq. The fact of the matter is if Pro-140 is everything most of us believe it is this play is going to either prove us right or wrong. Let’s be honest the OTC and Paulson raises have been killing this investment.
We are rolling the dice and moving to the land of opportunity. If we have something of value this move will be applauded with a buyout by years end. If we don’t let’s find out sooner than later.
All IMHO
The vagueness in the PR is all about complying with the FDA. This PR is positive in every way. Definitely making a change to remove the placebo arm. 10 patients was where the bar was set to evaluate the efficacy of such a move. The negative spin from the usual posters that are bearish is no surprise.
Couldn’t agree more Chump. This is all about the end game. The middle is painful if you put yourself through the daily SP.
I’m on the same page tonysd57.
My thinking is we are protected from being bag holders because Pro-140 has value in the Combo space. The question is if Mono Interim is not encouraging what will Pro-140 be worth. My thinking is worst case $2 per share.
Am I bullish on the potential Mono results? I think the efficacy was lagging behind the 70% mark. As Trding posted recently the subsets of patients need to be identified to increase the efficacy percentage. The company obviously is focused on identifying those patients profiles while increasing the standard dose to 525ml to hopefully increase efficacy.
I’m cautiously bullish because there are so many possible outcomes varying from exceeding 70% efficacy on all patients in the Mono Trial to achieving 70% within identifiable subsets of patients to not achieving 70% and having to design a new trial to pursue a Mono label.
My understanding is 70% efficacy is important to the FDA to convert from the current Investigational Trial to a P3 Pivotal Trial and also important for physician adoption. The 70% is most important to shareholders because Gilead and the major players in this space have to move for obvious reasons. BP is not going to move on Pro-140 as a Combo addition however the smaller players looking to generate $500M in the Combo space.
My expectations on Mono Interim are cautiously optimistic. I’ve been in for five years and I have no intention of selling a single share until we are purchased.
All of the above IMHO.
Originally every patient started with 375 ml and was increased to 525 ml if they were rebounding. They began starting all new patients on 525 ml regardless a couple of months ago and they need more data on the 525 ml group.
Trding articulated the predicament best-Talking about efficacy in subsets, etc. this is all about drilling down and cracking the code for Pro-140’s optimal dosage and patient profile.
IMO Mono Interim is the major event coming in the next couple of months.
They are events but not the same magnitude as Mono Interim. GVHD is exciting but in very early stages. BTD would be a nice lift. Compelling Mono Interim forces BP to wake up and protect their turf. Just the way I see it Michel.
The other presumption that Mono Interim will be strong as in stronger than P2 is a big unknown right now. Mono Interim has to show 70% efficacy at a minimum of 8-12 weeks to get the ball rolling with the FDA to convert Mono Trial from investigational to Pivotal. My guess is they increased standard dosage from 375ml to 525ml because they were falling short of the 70% efficacy. The 70% efficacy is not mandatory for Pro-140 to be successful but it radically changes the length of the trials and the need for additional trials. Believe me Mono Interim is going to dictate how long we a wait for a pay day as well as valuation.
Golden, I understand your logic. I would prefer avoiding an R/S especially if it would not be needed. The issue is they can’t wait and continue down the OTC road thinking everything is going to work out. Tony is going to get aggressive and tap into a bigger market with more exposure and options to raise $. No more sitting and waiting for an organic uplist.
Two major events and I believe their timing will be close together.
R/S and uplist followed by Mono Interim Data. They are waiting until they have sufficient Mono data to get BP’s attention and also enough to persuade the FDA to convert the Mono Trial from investigational to a Pivotal P3. Remember they upped the standard dosage from 375 ml to 525 ml a couple months ago. They need enough new data on the increased dosage to assess their Mono potential. I’m thinking late April - May is when these events will come together and at that point we are going to have a good idea if Pro-140 is a disrupting drug or just a viable Combo player. If the Interim Mono data is strong we will be done with this play very soon.
AIMHO - GLTA
Grip, obviously nobody has crystal ball and where the SP goes from here on a short term basis is a guess. I have never sold a share and averaged in about where we are right now. Seems crazy to have been in for 5 years and I’m even. Wished I’d got in at .50 and matching warrants but that just the way it goes.
My take is we now have a drug that will at least make it to market in the Combo space. If Mono Interim is strong then we will have BP’s attention and a buy out will happen this year. The question is how big of a position do you want and are you willing to hang until the end game. I wouldn’t want to gamble on a better entry point than right now.
Thank you Lawyer, that is very well stated.
Just an educated guess Luv.
Because they are hungry to raise as much $ as possible and flushing warrants is a positive even at .50.
Luv, that’s my take, worst case $3 per share unless something comes up as a safety issue. It is highly effective in CCR5 period.
As for warrants I am going to convert my 1.35’s although not today. They are going to extend at least another two weeks if not another month.
GLTU
I didn’t directly answer your question Grip. No, at the moment they have no intention of taking Pro-140 to market on their own.
Grip, remember Tony’s experience with Gilead was VP Manufacturing. It would appear he is going to take Pro-140 down the commercialization path to increase value. I don’t understand all that is entailed but there are many steps. One of which is having an inventory of $20M tested Pro-140 on hand. That is also a requirement as part of the BLA process.
IMO they are going to move ahead with BLA Combo this summer when they have the required safety data completed. We will also know Mono Interim at that time which hopefully will be compelling enough to force BP to move. Regardless they are going to move with the Combo BLA and the more of the leg work that is completed by Tony with the manufacturing and commercialization groundwork the higher the price tag even if it’s only going to be for Combo.
I don’t think they are at the buyout stage right now but I think they are optimistic that if Mono is compelling, more than one BP is going to make a move and this will be over this year. Clearly Mono Data is the potential game changer and grand slam.
Mono Interim in 2-3 months after R/S.
BD, you summed it up. The reason for the R/S and uplist is for all the positive that is happening with the advancement of Pro-140. I’m not a fan of R/S but in this case it make sense.
Tony needs a bigger audience with deeper pockets to command the valuation Pro-140 warrants for negotiating purposes. If it’s Combo and that’s all she wrote then it’s $3-$5. If the Mono Interim Data is compelling in the coming months all bets are off. I know they increased standard dosage in the Mono Trial from 375ml to 525ml. Mono Interim is going to determine our valuation and bargaining power. Gilead and Viv will have no interest in Combo as they will leave it for the smaller players. On the other hand compelling Mono Data will bring them to the table. Fingers crossed on Mono Interim. AIMHO.
My share count includes warrants. I won’t touch my .75’s at the current SP. I do have 30k warrants at 1.35 so I’m probably going to move on those. I also own 100k warrants at .75. If this hits big paying an extra .25 on the .75 warrants isn’t a big enough deal IMO. If the SP was over a buck I would consider.
I have followed you I Luv. We are in the same boat. I’ve got 500k shares. Just waiting it out and trusting Tony to get this to an end game sooner than later.
My read on Tony is he isn’t a pleaser he’s a gamer and a seasoned professional in the HIV space with his many years of heading up manufacturing at Gilead. He knows what needs to be done to prepare the infrastructure for Pro-140 to get the maximum pay day. He may seem to be in the shadows but that is not the case.
IMO uplisting to the Nasdaq is front and center right now. Somebody should ask why he feels so strongly about this on the next CC. He has his reasons and they are all related to what he considers his number one responsibility; ROI for shareholders. As far as explaining the details to shareholders I would say that is not his strong suit. I know many here would like more transparency and communication from management, as I would. The reality is we are never going to be satisfied with what we get in terms of the details until we cash in. Tony’s job is to focus on the details and get us to the end game by advancing the trials and generating awareness of the story. As much as I’d like to get the play by play and be treated as a board member it’s not going to happen.
I initially invested in the strength of the science and market potential that Pro-140 possessed. To me that is a given as the data has never let us down. The reality now is we are invested in Tony’s leadership and ability to make the daily decisions that add up to a buy out.
I’m Bullish as ever, just fed up with the Paulson raises. Uplisting is a potential way out. BTW I have total respect for those here that are against a R/S. I get it. The bottom line is it matters little what our opinion is as it will have no bearing on the outcome.
GLTA Longs.
Fred, you are baffling. An investor purchases at .50 and the SP closes today at .69. They are up nearly 40% and that calls for a lawsuit. Your thinking is far fetched to say the least.
I’m disappointed in today’s SP as I’m sure most are. Am I surprised given the timing of the 20 million shares that were offered at .50 with matching warrants? - no. It’s more of the same Paulson scenario we have witnessed over the last five years.
Once again it’s simple math. Invest $100k and get 200k shares and 200k warrants. Regardless of a wise investors belief in the science and value of Pro-140 they are going to most likely recover their $100k, and make 30-40k profit and own the rights to 200k risk free, no skin in the game warrants, and move on to the next opportunity. I mean seriously if someone said I will pay you $40k and give you 200k warrants at .75 and a five year window to cash in would you take advantage? Obviously it’s not quite that simple but that is the strategy. Peel another layer of the onion back and it is obvious that the investors in this last raise signed NDA’s and they were restricted from buying on the open market. Somebody fueled the rally last week by leaking the upcoming Combo PR and boom a 40% run up creates a nice selling opportunity.
IMHO we absolutely have to R/S and get off the OTC to change this dynamic by attracting broader investment while creating greater exposure to the strength of this story. Paulson is sucking the blood right out of our investment with every raise by flooding the market with cheap shares. In talking with management last year when Tony stepped in the priority was to discontinue the toxic warrant backed Paulson raises yet here we are doing the same two step because that’s the only game in town. So the Tender Offer is thrown into the mix to try to avoid Paulson. Well they just shot themselves in the foot with this last raise because the only warrants under serious consideration are the 1.35’s and there are only a few million of those.
In addition the delays have contributed to managements options in terms of raising of capital because time is money and no news translates to dilution at a low SP. The disconnect is the strength and progress of the science screams a $2-$3 SP. So the question is - how much more data and exposure will it take to create a tipping point? I don’t think management is going to sit idol and wait as they will move quickly to R/S and uplist so the opportunity to invest and attract capital is broadened. Its time to roll the dice folks.
Honestly Ahab I didn’t even read your post before I made the same comment- Bravo. Just struck me as right on the money. Thanks for your work BD. After I read Freds usual bias I felt you coming. Bravo.
Bravo BD.
I’m West Coast SF By Area but distance won’t be a factor for celebrating if this is a grand slam. To me that is first getting it right with Combo PE and then nailing 70% plus efficacy with Mono Interim. We should know very soon where Pro-140 stacks up.
I’m here and as bullish as I’ve ever been. Just playing the waiting game.
Grip, you have never been a Debbie Downer. Your a cup half full guy. Great to have you back in the game. Let’s see how far we can ride before PR.
Did you really clean house and move on Grip? I hope that was just a weak moment and your still in. I need somebody to play golf with in Vegas when we “put a fork in this” and it’s a done deal.
Great post BD. You nailed it. Thanks for taking the time to clarify - I see it exactly the same way.
You are correct there has been some drop out but not for any reason other than the transient nature of some of the patients. The other issue is limited capitol to fund Mono Enrollment. They are waiting for Combo PE readout to go for a bigger raise so they can go at this full bore and uplist. The other factor is because the Mono Trial is investigational with its initial purpose being to supplement the safety data for the Combo Trial, completing Mono enrollment is basically of little value unless FDA agrees to converted to a Pivotal P3.
To be clear they are thinking that N=150-200 will be a large enough population if 70% efficacy (105-140) is attained to persuade FDA to convert from current Investigational Trial to Pivotal P3.
70% N=150-200.
My understanding is they plan to release Combo PE prior to the meeting with the FDA. So the answer to your question is yes. The primary reason for the pre BLA FDA meeting is to review the Mono data to see if there is enough strength to convince the FDA to convert the Trial from investigational to a pivotal P3. That opens the door for label expansion beyond Combo. My sense is they are very confident regarding Combo PE while the efficacy with the investigational Mono Trial is close to the all important 70% line. That is why the dosage has been increased where needed.
More specifically Combo PE is not tied to Mono results.
Good for you Pears. I talk to Tony on a regular basis and I can tell you he’s not going to answer your question on the when the Combo PE will be announced. Do you feel any more confident in your investment?
It’s about time you picked up the phone Pears. If you are persistent you may be surprised with the response. Best of luck.
Hopefully meaning Combo PE PR prior to Feb. 28. The Tender Offer will likely stay open through the PR whenever that is. The TO is being strung along similar to there raises - just enough to get to the PR to see what the impact will be on SP. Like watching ice melt.
That is precisely the game that is being played BL. Been going on for years with the Paulson raises.
The warrants are no risk holds so the shares have been sold even at a slight loss in favor of controlling the warrants. Do the math and it’s a no brainer. That is why the SP never goes on an extended run before being slammed by selling pressure created by these raises. I, like some investors here have all my original shares that were part of the Paulson raises in addition to warrants. I looked at as if it was a great deal to own both. In hindsight the seasoned pros look at it quite differently - eliminate all risk by dumping all shares and holding warrants only. There were restrictions on my deals with Paulson that didn’t allow for any shares to be sold for at least six months. I don’t know if the same restrictions apply with these last few raises at .50. Even more interesting is how difficult it is to get your shares out of RBC where the shares are actually held. It’s not easy to transfer OTC penny stocks. It is quite a game behind the scenes.
The people that do this for a living look for these opportunities everywhere they can to stack warrants while selling all their shares and looking for the next deal. The only risk is low volume trading and a SP that drops significantly below the purchase price so one could get stuck holding the shares. How would you like to have 500k CYDY warrants and no capitol at risk? I have brought this up with the company and they aren’t stupid they know this is the double edged sword. They know it’s imperative to get Combo PE PR’d and get away from the Paulson gig and raise capitol in a much more productive way that doesn’t involve warrants. That’s why they are raising just enough to get to the PR. Getting away from this type of raise is another reason for the push to R/S and uplist. Institutional investment and much more attractive options to raise money.
In the macro view none of this is going to matter if the efficacy and safety is what most here believe it is. IMO Meeting Combo PE is the tipping point that will supply the proof that Pro-140 is for real and on the road to approval rather than just another pie in the sky biotech play.