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If you haven't already seen it, it is on their website. I don't really put much stock into these events but listening to Chew and seeing the presentation is interesting.
http://www.cormedix.com/investors/presentations-and-events/
Yeah, could be. Dr. Chew was a good speaker.... confident, somewhat inspiring, and knowledgeable. They kinda sorta explained what their angle will be with the FDA which does make sense. Basically, the delay resulted in a huge sample size resulting in a much longer and larger phase 3, so why need an additional phase 3? I think the argument will be successful. A little dissapointed they are only seeking approval for hemo at this time (as I understand it), but I sensed a hint of them trying to get full go approval for hemo with oncology and icu with concurrent phase 4. Regardless, the presentation was convincing in my opinion and further cemented by bullish sentiment. Good luck to you!
I'll leave the charting to you Janey. Definitely not my strong suit! But I like what you are seeing.... Good luck to you!
Yes, and final follow up from last patient dosed is about a month after. October is best case scenario for meeting with FDA. I hope you are right but also don't want then to rush in without all their ducks in a row. They have so much riding on this meeting they gotta get it right. If hopes are for October, could be dissapointed. Good luck to all!
If I am BP, I am waiting for FDA to give all clear. Why spend $XXX now with even minimal risk when you only have a couple months to hear from FDA to ensure CRMD's lead product is 100% derisked? IMO, big deal coming after FDA ruling (if favorable) but before NDA filing. Just makes sense to me as CRMD needs more resources to complete FDA and BP gets a totally derisked asset. That puts a deal (if a deal happens and totally in my speculative guestimate) around January of next yr. Just my opinions with a lot of speculation. Good luck all.
What's up guys. Took a break from posting for a while. Still here and still bullish. We should now be at a point where the final follow ups from the final trial participants are wrapping up according to the timeline they provided in their CC that I posted a few weeks back. If interested, I posted the timeline on 8/16. Now to scrub a plethora of data to be complete by YE. Note:. They were clear, the final data scrub does not need to be complete before their meeting with the FDA which is scheduled for Q4. I recommend patience....Q4 doesn't mean October 1st....it means 10/1 - 12/31. Outside of a major deal we got some time before any major announcements.....but the end is near. Looks like we've had some accumulation going on which is good, but continue to expect some major volatility over the next couple months. Good luck to all!
Let's not get crazy now!
You too. I got a feeling you will be back with a long position at some point. Good luck to you.
Hey man, not cool. Rapture has been here for a while now and has been nothing but cordial and respectful with his posts. Besides, money doesn't make the man/woman anyway. It's all relative to everyone's circumstances. $90 to one could be $9M to another. If I took a joke badly, then I sincerely apologize....Just don't think it's right to mock others over things as trivial as how much money they have. Makes you look small and those kind of words can hurt someone innocent who is really trying. Good luck to you.
Totally get it and good luck with those call options. I hope you get to exercise em! Take care bud.
Thanks and I appreciate the feedback. Don't blame you for being on sidelines, but keeping and eye on CRMD. While I am not a pumper who thinks a BO or partner or FDA feedback is going to happen tomorrow, given the current state of affairs, I wouldn't be surprised if a deal happened soon and could provide you with a reason to enter, unfortunately, if that happened soon, would most likely be a bad deal that wouldn't provide Max value - but could still be good. They already have an active money banks investor in Elliot who has taken a lot of control including appointing board members and inserting "their guys" to oversee management. The problem is that while they have provided significant funding, it has been to their advantage as opposed to all shareholder advantage. Check out what happened with that $2M backstop series F stock purchase Elliot did in 11/17 and the subsequent damage it did to the stock price due to the 3/31/18 conversion date. With that said, Elliot does provide at least a "money guy" that CRMD has while negotiating deals.....and my guess is any deals being negotiated will have a seat in the room for an Elliot representative. Man, I could go in, but gotta get to work. I do agree with most of your comments, but I fear a partnership more than an RS to be honest with you.....not that I think it would be bad, but I fear some kind if milestone based payments with low royalties basically leaving us in the same place we are right now. No money, a less definitive timeline, and the loss of Neutrolin control. I can go on later if you'd like. Still long, still bullish! Good luck buddy!
I rarely look at the PPS of today or tomorrow or clamour for some kind of PR for a quick PPS rise so I feel better. I tend to look towards the future; however, at this point, something's gotta give or CRMD risks will continue to grow. The entire float traded what 5x or more over the last month? Not a lot of strong hands out there. The timeline for hearing anything FDA related is sometime in Q4 according to the conference call. You know how much damage shorts can do in a span of a few months with weak hands and uncertain future capital concerns? The core issue now is that the MC was/is already ridiculously low. As the value continues to decline, so do our options. No BP will pay fair value if MC is 30,40, or 50M. For those thinking a loan is a good idea, good luck getting good terms without any real revenue and a horrible valuation. A partnership may provide some up front payment, but good luck getting even double digits royalties. Yes I am still long and bullish but we need something to drive value or we will leave a lot on the table once a deal is eventually struck. Honestly, I am not going to pretend I know how to do it, but they gotta figure it out and a simple PR for a quick rise won't work, it will only invite shorts even more. Gotta eliminate cash concerns somehow. Heck, they don't even have many shares left for ATM and at these pps levels, we don't want it anyway. I am almost at a point where an RS might be our best option with small ATM sells as needed. At least we could then show availability to capital when negotiating....yeah, I know it's crazy, but something has to give for us all to eventually realize Max value. Just venting. I seriously don't care about near term PPS, but when I see how it can affect the end game (which I believe is close), I start to get frustrated. As always, good luck to all! Still think this is a home run.....but I think it could be a grand slam if properly managed! Just my honest opinion. Good luck;
Fisher Man - I couldn't agree more with your post. Well said.
Agree. It's a shame what they are doing. I get it and it's all part if it. Just don't like seeing little retail guys & gals get hurt. Still long still bullish.
Orangecat - you packed a lot in there. Good luck with your other stock. My assumption is that you can expect expenses to go up significantly if they are starting their first phase 3. I do think CRMD is at a negotiating disadvantage without a solid balance sheet. I am kind of hoping Elliot is in the room when negotiating and informs any other company who brings up cash concerns that if it's not a good deal, they will continue to fund so money is not a concern. I do think either a partnership or BO is likely if not needed to continue into the manufacturing, marketing and distribution phase. Good luck!
I think I saw what you are referring to on a different board. I don't disagree but it would come down to the terms. I have seen it work both good and bad. I would say if we plan to partner or buyout, keep running on empty and debt free. If we plan to keep it in house, it could be an option to buy us some time.
This March calls were really cheap and if the timeline we were given works out, it could be a great play. Regardless, your mindset is really good. You thought it out strategically, but understand the risk. I really hope it works out for you! Good luck!
I hope those calls work out for you buddy. Yes, Idunno covered it pretty well and provided some good links. Basically, as they expire more are added. Good luck.
Timeline was very clear in the conference call:
Aug 4 = last dose of trial participants.
Sept 4 (or about) = Final follow up of last participants
Current - December = Scrub interum data and gather all subsequent data then lock
By YE = Turn locked data over to Biostatistician to unblind
By Q4 = Running parallel to above, putting initial package together to meet with FDA on path forward.
Q1 2019 = If FDA approves and we go straight to NDA, expect filing in Q1
This is point where current cash get us.
Other things that were mentioned without timelines that are ongoing and major impacts:
1. Ongoing negotiations with CRO. Note:. I did find it interesting that we owe them 8.7M in unpaid bills, yet they are still working with CRMD to wrap up.
2. They are looking for a partner. Note: It was interesting that they detailed how hard it is to get a drug to market being so small.
3. They are looking for "opportunistic" financing. I found this to be an interesting choice of words.
So it looks like no major developments or PR in the drug trial, approval, or results will be announced until close to YE. But there are a lot of irons in the fire as we move towards (hopeful) approval. Still here, still bullish. Just my opinions. Good luck to all!
Good luck to you and your additional shares. Kinda half paying attention to the action today while at work. Seems like some odd trading activity at quick glance. Definitely some good buying opportunities in my humble opinion.
I agree.
I've been quiet lately cause I've been traveling for work, but here are my scribbles from the CC for what it's worth.
1. They are excited and confident about Neutrolin, but as most of the posters on this particular board already knew, we aren't 6 weeks away from FDA approval. Many on the twits would lead you to believe FDA approval is similar to grading a math test pass or fail. It is much more than that.
2. Liz articulated the final stages very well. Gotta wrap up the final enrolled patients, have to rescrub all pre-December 17 data and have to completely put together all subsequent data. This is a long process, but Liz seems like she is all over it and was a great add imo.
3. It does seem like FDA approval is a very strong likely hood with probably a Q1/Q2 timeline.
4. They are going to keep driving on empty. This is dangerous, but also a catch 22. Raise and dillute or run on empty causing uncertainty.
5. They have been drawing from the ATM at a pretty strong pace. At the market is much better than PO, but now we gotta keep an eye on the share count.
6. By my math, we are about 144M fully dilluted shares. Unlike many, I do think an RS is likely at some point, but I really don't fear one at this stage.
7. No resolution to CRO yet. We are technically withholding about $9M is payments owed. These negotiations are key and we need a resolution.
8. They are obviously looking for a partner, but I still think BO is likely. The closer to FDA approval, the better. Our financial situation does put us at a disadvantage in these negotiations though. I really hope we don't reach and sign a bad deal.
9. Sure, I wanted more out of the call, but I am still very bullish. I didn't hear anything negative about the drug or an hesitation when discussing approval. They seem pretty confident.
10. Expect retail to be disappointed thinking we would get something of substance. Heck, I thought we would get more, but I get the process.
11. I would really like to know what we are spending $1.5M per month on if no trial expenses?
Regardless of any negativity, we are at the end of a long process. I am very excited and think a possible retail sell off could open up more buying opportunities for very long investors. Just a few things off the top of my head. Good luck to all!
You bring up good points. It was a double blind study. IF and when they unblind (meaning the company sees the results), that is the point of no return for CRMD. The trial cannot continue. I believe their plan is to meet with the FDA who is allowed to see the results to make sure approval is a basic guarantee before unblinding to the company. So, DSMB recommends halt, CRMD did halt according to website, but until feedback from FDA, will not infringe upon their ability to continue the trial.
With that said, prior trials show great results, this trial is recommend to stop by DSMB due to good results, and the drug is for an unmet need - so yeah, there is a lot of excitement. The ER is where we expect to get their plans to move forward and speculation is we are near the end of the expensive trial stage and near the "we own an FDA approved drug that may result in SOC by FDA due to fantastic results that fills an unmet need drug". Yes, very speculative and mostly bullish sentiment based on unknowns. But I am extremely excited about the future possibilities offset with a little nervousness about capital issues.
Orangecat - Took a look and agree it seems very promising. If I take a position I will see you over on their board. Regarding you being a new CRMD investor, welcome to the board. Good luck to you!
Agree with everything you said. But to my original point, the collaboration included an equity stake in Juno, and CELG continued to grow their equity stake until they eventually acquired Juno. I could definitely see a private placement happen. Not many shares on the shelf, so may require an r/s which is approved to happen if needed. I would say that (Total speculation) if an R/S were to occur followed with an immediate direct offer to CELG, ( or another BP) that it could be a very good thing and not the death pill many think when they hear R/S.
If CELG is interested in CRMD but not ready to totally jump in, your theory is very possible. If CELG has CRMD identified as a buyout candidate, why not just purchase shares on open market since shares are so cheap and then make an offer. Every share they purchase on open market would be a discount towards the BO. I guess it really just depends on CRMD and CELG and their motivatiins JMHO. I know CELG is focused on M&A, not sure what CRMD wants though I speculate they want a BO. I am completely speculating with my comments above. And sorry for being such a wordy poster. Good luck to you!
As a quick reply to accumulation. CELG accumulated shares of Juno before acquisition. Would like to see the same here.
I am totally speculating, but my reason for CELG is as follows:
1. New Jersey based so they can take full advantage of NOLS.
2. Close ties to CELG with curent upper management overseeing trial 1 came direct from CELG.
3. CRMD said they took advantage of free office space offer. Just so happens the address is the same as CELG. So Cormedix is getting free rent from CELG. Sure, they took advantage of a government program and they never directly said Celgene was involved, but common on.... something is up.
4. CELG is heavily focused on M&A. Already spent $10B this year and are looking for more according to latest earnings call.
5. Cormedix offers a product that would greatly compliment CELG existing pipeline.
6. Cormedix is at the stage where CELG likes to buy. Cormedix spent about $165M developing their current pipeline. Now that it is almost guaranteed FDA approval, the risk is gone.
Once again, I could be way off base....and you would think if CELG was involved they would start accumulating shares, which to date we have no proof that they in a single share. So while I think CELG is front runner, I could be totally wrong. Heck, CRMD might not even be looking for a BO. It just makes sense to me that they would and Celgene fits the bill. Good luck to you!
Regarding FDA. Technically, FDA should review and respond within 60 days after submission due to fast track and QIDP designations. Fast track allows for ongoing submissions of information as obtained throughout the trial process which allows for expedited review. Instead of everything at once, info is steadily flowing. Now, has CRMD been submitting info early? don't know. I think the whole 60 days is possible but unlikely. The info is not just on the 28 events, it's on all 700 patients involved along with prior trials. It's a tedious process. It will probably take just as long or longer just to submit to the FDA. And they won't submit anything until they meet with the FDA and review info. They won't submit unless they are 100% sure of approval. And just scheduling these meetings takes time. I may just be tempering expectations, but I think we got till 2019 before approval. Still, just a PR about filling an NDA will pop the PPS. Good luck to you buddy. Remember, these are just my opinions.
Oh, and lawsuit doesn't look so good so far....but CRMD has no money to fight this in court which has been a huge issue. BP would spend the money to win this suite imo. Good luck!
Real long shot of anything concrete regarding a BO. But I do think we may get some anecdotal information of their thought process and might even hear if BP has shown interest. I always thought Celgene was a good fit and they have a lot of ties between them. I read the Celgene conference call and they said several times they are looking at M&A to add to their pipeline. This is kinda how it works now. Let nanocaps spend $150-$500 developing a drug then buy them out. It takes the risk out for BF of spending capital with possible failure. So I do think this is a very viable outcome....just not sure if this happens until FDA approves. Good luck man!
Could be right.
Very well aware and if selling shares, would much rather prefer an at the market over a long period of time than an announceed PO.. According to Cook in last earnings, only had about 24M shares on the shelf though But why suppress PPS now with ATM? Just let it run past.75 and collect on warrants. Got about 4M at .75 that expire 9/10/18. I am sure they pulled from ATM in Q2.... just doesn't make sense to flood the market now at .5 - .55 if they could just allow PPS to breath and cash in on the warrants. I think shorts drove it down to cover. Total speculation on my part. Good luck to you!
I am expecting the following:
1. Update on negotiations with CRO. Has a settlement been reached and does it include financial considerations?
2. Update on how they intend to raise and use capital. Continue with bare bones budget, or raise enough for 12-18 months. Standard type raise either PO or DO, or something off the wall like trying to sell a portion of NOLs for instance - which I have not vetted, but understand is an option.
3. I am certain talks with the FDA have occurred. Update on these meetings and pathway to approval. More trials needed, more info needed, or intend to file for approval now.
4. Future plans in general. Are they shopping for a buyer or partner, or planning to see it through to market.
These are the updates I am most interested in. If they eliminate capital concerns, there is really nothing holding it back. If they intend to go right to approval and have solved capital concerns, then extremely bullish. Good luck to you!
Just to speculate a little, and knowing I am a long term outlook guy, not a daily or short term outlook guy (so I am not the best source of short term info) I think shorts are tipped off and on alert to walk it down and cover now before ER. Usually MM would help build up to ER but be short to drive down and cover after ER cause ER for nanocaps are basically always bad. I guess we will see, but I think this ER is gonna be filled with very substantial information, and shorts know it so they are taking advantage of inpatient retail now. Totally speculating, but I feel pretty good about next week and the action this week has done nothing to change that sentiment. Good luck to all!
There is never a need to buy anything quickly. Maybe just watch it for a while until you are comfortable. I haven't purchased any at this point. Just holding and adding to my long position. But I will keep an eye on the options market.
I am a blue chipper and I only put about 5% of my portfolio in nano and small caps. I do my DD and pick 1-3 to invest in. And I take a long time before I make a decision. I don't always win, and I have made some mistakes. I don't day trade. Right now, CRMD is my only nanocap and I remain supremely confident. I am watching several others, but am watching ISR VERY closely and will probably enter before YE..... probably being key. Everybody gets one ??.
Yeah, this has been a relatively quiet yet very respectful board of all opinions. Regarding Europe. Yeah, sales already but minimal....about 300K. IMO, they pushed European approval for additional efficacy proof when presenting to FDA. In Europe, they have a ton of competition and don't spend anything on MKT. Theory is with FDA seeing huge efficacy, could turn into SOC taking a big piece of the US pie and, increase overseas market share with the new approvals and test results. FDA approval would also allow for faster approval of other pipeline products. The $2B was simply saying I could see it and not necessarily a projection.....but the NOLS we carry along with QIDP designation does offer huge upside for Big Pharma. And we got a decent pipeline too. Given market potential and the added upside, north of $2B isn't outside reality but is definitely optimistic. Annual burn is around $33M, so in theory, company could be in the black in less than a year of sales if they partner. If they stay in house, would need a ton of capital to manufacturer, distribute and market. Projections in this case are less clear but within 24 months should be expected. I really do think buyout though....I just have a suspicion that Elliot is ready to cash it in and go home. With that, we may not get as much upside as possible, but Elliot is not known for taking small offers. They wanna win big in my opinion. Bottom line with this company is whatever comes out of the meetings with the FDA. Huge risk reward.....we are talking about $0.25 - $15.00 PPS risk reward. Most bulls will argue $2 - $5..... I think that is low, but certainly possible. Most bears point to dillution and Europe sales. I totally get it and the argument is fair. But nanocaps always need money and their is more to the low Euro sales than the number. The above is full of speculation and opinions. Good luck all!
Welcome to the CRMD board! Fully dilluted, I got them at around 129M. Includes all outstanding options, warrants, and conversion of other series of stock into common shares. I think the number you were looking at didn't include the conversions of series C,D,E,F shares mostly held by Elliot. This is probably a little high as they have warrants as high as $7 I am including....but you never know and I took everything into account. The huge spike you refer to is 2 fold. Fewer OS and buyiut talks.... Rumor is Elliot and CRMD was looking for a buyer. Still, if memory serves, the MC was up around 250M+ at the time. Either way, it didn't pan out. Plenty of buyers, just not high enough.... Since then, bad double warrant financing followed by pH. 3 delay due to CRO foul up resulted in decline. I actually see no reason by a $2B buyout isn't possible, but only if FDA goes along with DSMB (which they tend to do). Financing is the issue right now. They got an existing ATM they use sparingly and .75 warrants with an exercise date if 9/10. Most are held by insiders and Elliot which lessons the shorting risk - if exercised (and I believe a few were after the pop to .8 from my sources), would be at least some funding but would cause some resistance. Personally, I think BO in next 6 months if FDA stuff all goes as planned and I think it could be big. If they need capital, may do a 1:5 R/S with small raise. Either PO or DO....either way, Elliot will somehow be involved. Basically, huge possible winner, but don't overlook the risk. These are my opinions only with a lot of speculation. Good luck to you!
Idunno & Rapture, great dialogue and Idunno, you are better at explaining than I. I am still struggling with the 2.5 strike even tho they are certainly cheap and may be worth a play. You are right that if BO, it's a good move. If partnership, I am not sure we would see much upside with that strike. If bust, minimal losses. I am a big fan of the options play though and will be watching closely. It really is tempting at .10. If I know the investor/gambler in me, I'll probably pick some up. Good luck guys!
1 option equals 100 shares. The price I am seeing right now is 10 cent options for a $2.50 strike price with an expiration date of 3/21/2019. The option cost is per share, so 1 option equals 10 cents x 100 shares. so, $10 bucks + whatever fees you pay per your trading platform or broker equals the right to buy 100 shares at $2.50 anytime up until 3/21/18 close.
Options are traded sililar to regular stock purchases. There are asks and bids. So you could put a bid in for whatever you want, but the curent ask I see is 10 cents for a 2.50 strike price. If you exercise your option, you would need to pay $2.50 per share. So you would pay $250 for your 100 shares. Good news is you can only lose $10. Bad news is that you lose upside from .62 - 2.50. That's why I wish there was a $1 or $1.50 strike price......but no options for that right now.
I'm not sure if the lack of options means much of anythig. Some nanocaps have no options at all.
True. Looks like March call options are around .10. Might pick up a few. Take care and good luck!