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Sandra, impressive work. Can’t say enough about your contribution here. I’d like to send you an email. What is your best address.
The FDA meeting next week is to discuss BLA submission and review P3 Mono Investigational Trial to hopefully get green light to convert to P3 Pivotal.
The outcome of that meeting has to be PR’d. Hopefully it is very bullish. Is that why they raised $1M instead of more? IMHO I think they would’ve preferred to raise more. It’s going to take major news to open up healthier cap raising opportunities. Combo BLA acceptance by FDA and sparkling Mono Interim Efficacy 70% or better are the triggers IMO.
As has been the case for too long Paulson is our pimp and has us leveraged with no place to go. Company needs to do whatever is necessary to secure financing that breaks the lock Paulson has on the SP. If they don’t the SP is headed lower because that’s the only way Paulson will be able to continue the warrant backed raises.
Next week. They have to PR the outcome. When this blows it will blow. .70-.75 is not really on my mind. The value here will be validated once we know if Mono is to be taken seriously by the BP HIV players. I have to believe Mono Interim is part of the discussion next week w the FDA and we will know if this is a Combo play or combined w the huge added value of Mono. Pro-140 is no secret - the players in this space are monitoring the data. Bring the data - let’s get on w it.
This meeting is to confirm their house is in order in terms of preparation to submit the BLA. It’s like a checklist so management is looking for confirmation that there isn’t something that is going to be required that will create an unforeseen delay. Because the safety data from the investigational P3 is tied to the Combo BLA, Mono will be part of the discussion.
The major event is Combo BLA acceptance by the FDA. That takes place after the BLA has been submitted and the FDA reviews and finally accepts the BLA. Review can take a couple of months. My understanding is Acceptance translates to drug approval.
Just as Finesand has run valuations on Combo, management has outsourced this very important needed information. It will be interesting to see how the valuations compare but more importantly how an interested suitor will value Combo. Obviously if Mono Interim suggests a realistic shot at approval valuation changes radically. The thinking is to determine during the Combo BLA process if Mono is in play or are we going it alone with Combo. IMHO a deal has not been in the making because it is not yet known just exactly what we have on the table. Interim Mono Efficacy is a huge inflection point in the end game.
I’m not an authority by any means but that is the way it has been explained to me.
Rumor has it June18-20 window set for FDA meeting but what do I know. Outcome will have to be PR’d.
I too am hopeful Mono Trial will be discussed and given the green light to convert to Pivotal P3. Also anxious to hear Interim efficacy w the increased dosage.
To me BLA acceptance and Mono conversion are the needle movers. If BP looks at the Mono Interim and calculates there is a realistic chance for future approval it won’t matter what the SP is they will be forced to move and pay plenty.
Have to believe things are coming to a head. Can’t keep a lid on the valuation of this science forever.
I’ve had numerous conversations w Tony C. He has the experience and the goods to get a deal done. Quite frankly he is a big reason I have stayed the course. His network is broad and deep in the HIV space. He helped Gilead go from small to huge. I’ve always laughed when the badgers would say he was just here to collect a salary. Wow, really couldn’t be further from the truth.
The SP is totally controlled by the recent raises at .50 w unrestricted warrants. These investors are willing to loose a couple cents to control a boatload of warrants.
The bottom line is nobody of consequence in the HIV space believes at this moment that Pro-140 can actually get approved as a mono solution. Mono Interim w the increased dosage may radically change the odds and perception in our favor. Combo is a done deal but unclear as to its full potential until study is completed. So here we are on the cusp of gaining the needed data to clarify the strength of Pro-140 in both the Combo and Mono space.
For now we are stuck w very poor financing that controls the SP. Where would we be if Warrants were not part of the equation and the real market of supply and demand was able to operate freely?
I’m guessing $3 and no longer on the OTC.
With BLA acceptance by the FDA and strong Mono Interim Data a major tipping point is on the short term horizon - Q4 2018 IMHO.
That is exactly how I see this playing out with the warrants. Not only lottery tickets but free in many cases with those that dumped all their shares. I’m thinking BLA acceptance by FDA and Interim Mono efficacy above 70% will send the SP on quite a ride and greed may create momentum. We will also be in prime position for a buy out. We should have our answers Q4 2018.
This is why the company is very optimistic about upcoming results w increased dosage. Hopefully enough to convince FDA to allow conversion of Mono Trial to Pivotal P3.
Anybody who says the SP doesn’t make them nervous would not be being completely honest. It sucks being at the 50 cent mark. When one understands the reason we are stuck here the nervousness subsided a bit.
This is 100% related to the Paulson raises. The SP is not moving freely because it is being flooded with sell orders at .50 because Paulson investors have a strategy that creates a risk free investment.
Combo BLA acceptance by the FDA and or 70% plus Interim Mono Efficacy are the two events that would change the current dynamics.
I can tell you with the increased dosage in the Mono Investigational the company is feeling confident. Part of the BLA meeting with the FDA will discuss changing the investigational to a Pivotal P3.
IMHO your events are in alignment with managements strategy for June. ASM Combo Data and FDA BLA Meeting. Let’s see where we land around the last week of June when all the info stellar, good, bad, or indifferent will have to be PR’d. June is a big month as we should learn how cooperative the FDA is going to be with our BLA package in addition to the strength of the Combo data.
Will it be enough to break the bondage of the .50 warrant backed Paulson raises that have trapped the SP? Some light at the end of the tunnel would shift perception greatly.
I look forward to that day. It’s been a long journey.
TT, we can call the Paulson investors what ever we please.
The issue is twofold. Paulson is our only option at the moment to raise $ and the reason they are able to raise $ is because they promote risk free warrants and a way to build a position and get 95-100% of your $ back. In some cases even make a few bucks to go w their warrants.
The Paulson racket is better than going BK but quite difficult to be a LT shareholder. Our day will come.
This is the very core of the valuation that has to be understood and accounted for to realistically determine a buyout price.
“So this is one thing here, the calculated market-size - let it be $1B or $1.2B is assumed to be the complete cake where you apply the market-penetration onto.
WC Wainwright thought 8-12% for Combo and of course much higher for Mono, maybe over 20%, in the first years.”
The Interim Data from the Mono Trial could absolutely be the tipping point if it is compelling enough to make Gilead and the likes nervous. The big boys are passing on Pro-140 as a Combo play for the time being. They will not pass on Mono if it appears to have a realistic shot at threatening SOC.
I love that song by Michael McDonald.
“I heard it through the grapevine”...take it for what it’s worth. AIMHO.
I don't think people understand what is taking place here with the SP. The .50 warrant backed Paulson raises are controlling the SP. Paulson investors are willing to sell at a slight loss to gain control of risk free warrants. This has nothing to do with the value of Pro-140. If you've got money to play with buy now and look like a hero when BLA is accepted by the FDA and Mono Interim data comes back above 70% efficacy. The scheduled meeting in June with the FDA will shed some light as the outcome will have to be PR'd.
All good questions that I don’t have the answers for. I could speculate but that is guessing. Here’s my guess...yes capital constraints have limited the speed of enrollment. Why all the silence? Either no news to report and/or significant news is close at hand. Again speculation.
That’s the question I keep pounding the company with. Problem is they don’t have enough patients/data that are on the increased dosage. If Mono Interim comes in w greater than 70% efficacy that should kick this into a complete different environment. I just don’t know how close we are.
Your spot on E.
I’ve invested three times w Paulson. Problem is not at the fire sale 50 cents w matching warrants w no restrictions. Hind sight is 20-20. I’m holding what I’ve got and not interested in buying another share. Should’ve, could’ve, bla bla bla, if I could do it over I would participate in all the Paulson raises and sell all shares and accumulate warrants and sit back and relax with no $ in the game. That’s the strategy that is holding the SP hostage.
Live and learn.
For every negative there is a positive. I’m happy for you Dolph.
This is a situation I did not anticipate a couple of years ago. The delays are what has created this scenario. The difficulty and complexity of enrolling Combo cost us dearly. The reality is efficacy and safety are strong but execution by management has faltered. If confidence was high the warrant holders wouldn’t dump their shares.
I think Paulson sells these raises by telling their accredited investors their is almost zero risk. Pay your 50 cents a share and then sell them and keep your warrants. You can have your position with zero risk. That’s a no brainer as long as their is enough float to move your shares. The SP can even dip below 50 cents because their willing to take a small short term loss to hold the warrants to wait and see for five years.
This has nothing to do with the value of Pro-140 other than we are trapped until better financial options become available.
BP loves to see us caught in this predicament. We need a major PR to stop this cycle. I don’t see the June ASM as being that event but we shall see. BLA and Mono Interim May do the trick.
Yes us long time Shareholders have really taken it in the shorts. Here I am averaged in at .80 on 500k shares. At the end of the day it won’t mean a whole lot if/when we are purchased but right now it makes me sick. Giving the company away to Paulson because they have no other option to raise $ at the moment. My question for Tony is what is the plan to change this predicament?
Can you imagine what the SP would be if Warrants were not part of the equation. The only people selling are the warrant holders. This would run to real valuation in a heartbeat.
I’m here.
You need to network your way in to Paulson and get approved as an accredited investor. Net worth $1million and annual income I believe min 200k. Its a bunch of BS but their are hurdles to qualify to take lesser risk than buying on the open market. Lol. The big difference is your shares are restricted so that’s the reason for the barrier to entry. I own 100k shares purchased on the open market and my average is lower than my much larger Paulson position. At this point if I was starting a position the Paulson matching warrants at a fire sale price would seem to be the only way to go. I will tell you these small raises subscribe overnight as they are sold to previously approved credited investors.
On another note. The recent minuscule Paulson offering is a non event as they will continue to raise in small increments regardless of how bullish they are regarding the news around the corner. There have been events that management absolutely believed would move the SP that did not so they are cautious as to expectations that great data at the June ASM will finally turn the tide.
Sorry to throw a bit of a wet blanket on the current situation but that’s the way I see it. I’m still a believer that the science will have its day, however the warrant fueled Paulson raises have and will continue to keep a lid on the SP. Currently that lid is 50 cents. Until we break free from Paulson thats where we stay.
Finesand is on track as to the calculated market valuation of Pro-140 and the events that will bring the current SP into alignment. How much evidence it will take is the debate that constantly takes place here on this forum. As one wise investor stated long ago on this forum, you may want to manage your energy on a monthly basis rather than a daily basis with this type of investment or you will become fatigued.
IMHO we need a partner with the resources to commercialize Combo and expedite Mono Trial enrolled to push the envelope. Bottom line is Combo got bogged down and economically compromised Mono enrollment. Mono should have been completely enrolled last year. Time is money and time is kicking our ass at this juncture. BP knows our predicament and they are hoping we run out of gas. As Tony C has said biotech’s don’t go BK from diluting, so we will keep on advancing the clinical trials with the hope that a tipping point is inevitable.
GLTAL
Couldn’t help myself. Added another 30k shares today at .52- loaded up for the end game.
Exactly. It’s called validation.
I’m no expert on why or when we will get our deserved attention that translates to a dramatic increase in Pro-140’s valuation.
I will say that it’s all about risk vs reward for the suitor. One taker that sees value will rattle the fence sitters and change the perception of Pro-140 and we will be the new girl in town. We just haven’t reached the tipping point yet. With what is in the pipeline to further validate I don’t think it is a question of if it will happen. It’s a question of when and how much $.
Thank you. That adds a bit of a punch. In the past these presentations have not moved SP. I hope this will prove different and start the ball rolling for us.
We seem to be on the same bullish page. Not really much I disagree with in your posts.
Can you tell me what is meant by late-breaking session?
“present these results in a late-breaking session at this year’s ASM Microbe Conference,”
Is there a difference in this presentation from the norm at ASM?
Thank you for your number crunching Finesand. I know the company is doing their own DD determining the market value of Combo using several different scenarios as you have done here. Why not send Nader or Tony C your analysis and ask for their opinion? I would recommend Nader.
My take is while Combo certainly has revenue producing valuation in the HIV space it is not threatening BP at this point in the regulatory process. As the specifics on the CD02 trial are presented and revealed the urgency and valuation should shift but not to a tipping point IMO.
So if I’m a major player in the HIV space like Gilead I’m going to pass for now. I’m waiting for Mono Interim to see if Pro-140 is actually a real threat to my dominance. If the efficacy comes in strong above 70% with the same safety data I’m going to have to strongly consider the risk of doing nothing. Until that happens I’m not worried about purchasing another quiver in my current dominant HAART arsenal.
This doesn’t mean someone else won’t purchase Pro-140 for a revenue generator in the Combo space. If a smaller player can see a $500m annual revenue stream somebody will jump in. The hurdles are adoption rate by the Physicians and all the upfront marketing to break into the market after going through the FDA approval process.
So for now we are waiting for catalyst(s) that will tip the scales in terms of perception from “it looks like you have something” with Pro-140 to “yes you absolutely have something”. Perception by the market that pro-140 is a guaranteed revenue generating drug in at least the Combo space that will be approved.
My list of catalysts in no specific order of strength except for the Mono catalyst as a singular event which would blow the lid off the SP.
-ASM Microbe in June
-Completion of Combo CD02 in August
-Mono Interim Data- <70% efficacy/FDA approval to convert to Pivotal P3 with BTD
-GVHD news
-Partnership/Licensing Agreement
-Combo BTD
-BLA submission
Company is focused on small raises and advancing the clinical trials to reach the above catalysts. When the tipping point is reached the cheap shares being sold in favor of keeping warrants will evaporate because perceived value will be many times what it is today. The wall that has been created at .50 and then .80 is the market measuring risk and perceived value. We are in the midst of stacking up the preponderance of evidence to prove Pro-140 is for real. The first sign will be the SP running right through current wall(s).
You obviously understand the FDA process very well. I’m hoping someone other than the obviously big players steps up and sees the opportunity to generate revenue in the HIV space and get a foot in the door.
I agree that if they had the bank or a partner they could push the trials and commercialization at a much faster pace. Restricted resources have hampered progress.
IMHO Pro-140 is unique and could potentially disrupt SOC so the grand slam is still in play. Default is a revenue driver in the Combo space for a smaller ROI. So my thinking is in the end Pro-140 will be worth something rather than zero and possibly a boat load.
Thank you for your thoughts A17.
GLTU.
While I have participated in the past with Paulson I got in at .75 with 1/2 warrant for each share purchased. The deal today makes me vomit as I was too early in the game. I’m not willing to keep on piling up shares- I’ve got enough exposure.
I know Tony C hates this raising scenario but advancing clinical is the focus. We need significant news to gain access to more advantageous financing. A partner would eliminate it all.
A17, your probably more qualified to make that forecast than I.
At this point do you believe Pro-140 will get FDA approval for some type of label for Combo?
I know you have reduced your position and are hoping to break even. Is that still your outlook?
Thanks MJ, that was my understanding but didn’t know for sure. No restriction on the 50c raises means the cheap shares need to be sold before SP can move up.
Well said Gestalt. I’m with ya.
Agreed, question is how many cheap shares are still waiting to be sold. We have no way of knowing with certainty.
You make many good points and your concerns are understandable.
At the time of the scheduled R/S financing arrangements tightened to a level that management said no thanks in favor of waiting for better conditions-that’s all I know.
As for catalysts there will come a time when it will be clear that Pro-140 will gain FDA approval for Combo and that will crush the 80c wall and beyond. We are not there yet.
In addition the market is waiting to see if we have a realistic shot at Mono approval. Mono Interim is one such catalyst that could come behind Combo and blow the value to the moon. As we all know that’s the game changer.
On another note warrants are not being sold or exercised- they are being kept while selling the shares that were purchased to gain the right to the warrants. Participants in the private raise like the story or they wouldn’t invest in the first place, however when they know they can eliminate all risk by selling their shares to recover their investment and sit on their warrants it becomes simple economics.
Many here have participated in the private raises and taken a different approach choosing to keep their entire investment - I am one such example. The last chapter has yet to be written to determine if that was a wise move or not. Obviously I’m betting it will be.
I don’t know if all the raises at 50c were subject to the 6 month restriction. You make a valid point as I was subject to the 6 month restriction with the private placements I participated in. What we know is how penal this type of raise is to the SP. Having to match one warrant with one share at 50c is not what the company or SH’s want unfortunately it appears to be the only game in town at the moment.
Re: Saltz Post# 22196
“How is selling shares and keeping the warrants market manipulation?”
Relative to the daily volume that is traded the sellers are 100% warrant holders dumping their cheap shares they purchased for their rights to an equal number of shares with a five year shelf life requiring no financial risk. Call it what you like but publicly traded companies on the Nasdaq and Big Board don’t have that dynamic in play.
Further, yes they do anticipate data that will further derisk Pro-140-thus the reason to raise in small increments and uplist after the news hoping for a more favorable financing environment. That begs the question why wouldn’t they R/S and uplist and save the news to protect shorting on the uplist? It’s a double edged sword. Get screwed on the front end financially and ride the news after uplist, or ride the news for more favorable financing and less dilution on the front end. You tell me.