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Why is this dated 11/1/19??
Not understanding that.
Obviously I am very hopeful that the approval gets announced Monday or any time next week for that matter. I only hope this does pop good on that news and that the company has been in negotiations with NOVO for European (worldwide) rights and/or hopefully a buyout as this truly makes the most sense for a company the size of Novo with the resources they have.
I have been here for over 3 years waiting for Zoptrex approval thru the bullshit and lies of David Dodd and hung on because I felt Macrilen would at least get me back some value as I always thought that at least that product would make it to market (though like many I didn't realize the value of it)
So I guess we will at least know where we stand very very soon.
Good Luck to all
Brett
Well sir I certainly can not disagree with the insanity I have and my less than perfect investing style.
But I certainly can't compete with your amount of posts over the years as it appears you have been very active all these years while I took a long time off and didn't do much in the markets for quite a few years.
Hopefully you've done well for yourself.
Ive had one or two pretty good hits and many misses Hopefully AEZS will be another hit as it appears they are moments away from getting going.
Good Luck and Happy New Year I wonder if those guys are still involved in running this site or at all with the hub.
Regards. Brett
I assume you mean that I have been on the hub since almost its inception.
I believe Matt Brown was the name of the guy that was involved in staring this site with others And I knew of him and back them and posted back and forth with him a bit in the beginning.
I have come and gone over the years, but I a surprised to hear that if its true.
Thanks Brett
Good luck to us here on AEZS I think its close to us finally cashing in on this one
Any thoughts as to why such a sharp down turn this past week. I added a little more Friday but I wasn't thrilled by the sharp drop all week and even more downward pressure looks likely
I am hopeful that once they get European approval they might get something done directly with Novo. A deal or buy out, but Ive owned this stock for a long time and am use to disappointments
Good Luck
I read on yahoo someone saying there is or might be a cannabis connection in there near future. I do not know if that has any merit, but it could explain this recent spike in volume and price. It is definitely being bought up by some one.
We shall see
Waxman
HeyJoel
Nothing new really going on. They just released the quarterly and because of the strong bridge up front payment and some things they are working on the price has come back a bit. They are now profitable for the first time albeit not exactly a huge number. If they get European approval in a few months and can find a buyer over there with the smaller overhead the price should continue to climb.
Honestly the company doesn't have any huge logs in the fire unless something happens but at least they can be a smaller profitable company and have the opportunity to look for something that fits that can grow them beyond Macrilens potential. And when Macrilen hits the market later this year royalties will continue to give them profits.
Good Luck. Brett
I agree Ragnaroc. The stock goes from a buck to 3.40 or so on absolutely nothing but a coming FDA yes or no response on December 30th. Trades probably 40 million shares in a few days before settling back down.
Now they actually get an FDA approval and it does go up but not the bigger run up I expected. I thought for sure it would at least get to 4 and trade 10-15 million today.
I realize that Macrilen though a nice moment for the company is not a mega money producer. It will give relief to people who have to get tested and this will be a good thing for them, but with a 50-100 million yearly market it is not a huge money maker. And I do agree with what this company has they would likely be a good buy out candidate for who knows how much With the very low float and OS it could be 5-10 anyway. I guess for those that wait we will see.
Good Luck
Glad I bought back in on Friday I can recoup my losses from the last go round.
Do you guys still think this company is going to accomplish any of the things hey are striving for?
The waiting and missed dead lines is monotonous
maxim is a shill for the company
they are going no where unless and until macrilen get s approved end of year or something strange or unexpected and new happens
Thanks for your insight. Isn't the company claiming they are going to have these things being released in June and or July. July is almost gone. HeyI understand patience but all the stocks Ive made money o are the ones I take patience out of the equation and sell on spikes. I have failed to do that twice here and could have made some nice profits and re bought.
Ive learned these small bio techs rarely seem to meet time lines and often fail to deliver like AEZS another I had for a while. I just got out on the last recent pop and now do not believe they are going to succeed at all.
Point is these are very risky. I do like the potential for this company though I wish they had more exposure so they could trade more heavily.]
Good Luck. Wax
What's going on here
This thing has dropped almost 40% off there new 52 week high in three days. Any thoughts on this from regulars I have been here for about a year and was wondering what was going on?
Are you guys serious. What happened to make this go up?
Absolutely nothing. They did not get an FDA approval. They got a PDUFA. A date that the FDA will give a final decision. It was all momentum and perception and when it spiked up on nothing it will drop back down on the same. I'm shocked it traded as much as it did and went up as much as it did. And though I have no idea where it will go I would guess back to 1.50 range until they do something possibly with the new guy in charge.
JMHO
Hey Joelk I hope you can recoup some of your losses. Personally I sold the other day at 2.65 (way better than a buck) not knowing how much legs this would have so I cut and ran and the bleeding should stop any day now.
I cant even figure out why its run so much on news that says we have NOT gotten an approval from the FDA just a date they will decide by. Unless I don't know how to read English. And then two days later there's more internal turmoil and Dodd the POS is gone.
Head scratcher for me but I am out and wish you all good luck
Wax
good luck with that schlumpy. I have been in this pig for well over a year and yes I m a little bitter. I swallowed the Kool aid and believed in the shit they were shoveling. I would be shocked if this goes within 8 or 9 dollars of your projection. They have done very little to show there shareholders there is value in this company for anything but an in and out play. They have been deceptive in there PRs and even todays news is not an approval just a maybe. That is what this company has been selling to us. Maybes and sorries. They have one product left in there pipeline which if it does get approved will have a potential market of 40-100 million a year in 2019 or 2021.
I was thrilled to have a chance to get out today and blow a lot of money. But a lot less than 3 days ago.
My opinion is there will possibly be a pop in the morning followed by a sell off most of the day and within a week or two back to 1.50 or less
Good Luck
I honestly did not believe that to be the case. I thought you generally had to have an FDA approval before you filed and NDA.
I agree with the fact that it would be ludicrous for the company to release a PR saying results would be coming Monday if they were bad. But would just release them and hope its not a total disaster.
That being said I half expect the news to NOT be as good as we all hope for. Or I hope for.
And what I want or hope for is an FDA approval for Zoptarelin. I kind of expect the company to say results of the trial were positive and we are hopeful of an FDA approval and preparing to file an NDA and are moving forward and ready to launch "if" the FDA gives us the go ahead. And we expect to hear from the FDA soon.
Now why do I say this? First off we have seen nothing from this company to make any one believe they can truly GET IT DONE. And and this is a big and in my opinion. I have seen nothing from the FDA saying they have approved Zoptarelin. And I can't believe the FDA called the company and said we are going to give you the approval Monday morning. I just don't think thats how the FDA does it. And I am no expert on FDA protocol mind you, but I say this because I am signed up with there website and receive E mails from them 3 or 4 days a week as they approve drugs of all sorts for usage in many different areas. I have also done a search of there web site today and tonight and there are no results for Zoptarelin Doxorubicin, Zoptarelin, Zoptrex, Zoptrec. nothing. So I wonder why?
On the other side of the ledger, I wonder about the stock sale from yesterday First why would the company sell stock to raise capitol now if they are getting an approval and the price would be so much higher. And then I feel thats the only way they could sell it, is by making the buyer feel as though it was a lay up for profit and maybe the buyer wouldn't pay 8-10 or 20 because of the volatility that will likely come with that see saw of a ride we hope to be getting on. And the company is so desperate for additional cash to bring the products to market they have to do it. Also why would the buyer, buy now if results in 7-14 days from buying, would be negative and the stock may well go to a dollar causing the buyer to feel like they were duped by the company, which would make it virtually impossible to sell any more stock from this prospectus at a later date if they need to, (which the will).
Hows that for feed back from the dazed and confused investor trying to make heads or tails from this shit. Monday Monday what will happen
Good luck to us all
Nice catch there. It appears you are right that it is unlikely we will get results before May. Whether that is a good indicator or a bad one only god and maybe the FDA knows.
We the lemmings stand by the edge of the cliff waiting to see if we get pushed off or can turn back and feast on the positive results.
Also the second filing that talks about a take over bid is perplexing and hard for me to digest.
Dazed and confused
I agree. And I hate to say it because I have been hanging in there pretty tough. I am not expecting good news on Zoptrex. I think the stock will drop to a buck or so and I will have to wait for the third quarter lamenting in my misery and licking my wounds until I think they will somehow get the approval on Macrilen and the stock will then go to 4-8 bucks and I will have a shot to make some money
Of course I hope I am wrong about Zoptrex, but this company has done nothing to prove they can get things done in a good way. The only reason I wait is the profit potential is so big if it does get approved and there is enough positive research and the alliances with the other companies to make you think there is a chance.
Tic Toc. Tic. Toc
So the FDA said go ahead and file your NDA but prove to us you can hit the end point you missed on and your all set. The company earlier said they believe that they can hit that end point with just a dosage tweak. So its good news in that the FDA didn't say NO means NO. They said we like what you got but we still want to see you meet that end point. my take on it any way.
It is the middle scenario I was thinking could happen, but obviously not the one I was hoping for. That said it is some what good news. I don't think the stock reacted as well as I had hoped but what else is new. I just hope they can really meet the FDA requirement and get this commercialized. It does appear to be a much better option than the ITT.
My question is why would they need to borrow 9 million more now, if they have 21 million cash on hand?
And why now at 3 a share if they are going to have good news which would move price north making for a better situation to borrow. IE: if its 4.50 a share 9 million only costs 2 million shares?
Not loving this
It is with in days of months end and supposed news on FDA meeting. why now?
G.
It is hard to understand your English a little.
But I disagree with you on Macrilen. You are right the company did miss one of the end points from the FDA which apparently cost them an approval the first time. I believe the company is saying to the FDA that after going over all the info and having an independent source also check some things (like reproducibility and stimulation of the pituitary gland and ease of test and safety of test using the ITT as a comparative as the FDA did ) that they believe that Macrilen has so many positive aspects as compared to the insulin tolerance test that even with missing one end point they feel the product should get approved and move forward. Also the company said that with some fine tuning of dosage that they believe Macrilen can hit the end point it missed. So I believe the best they can hope for is approval of the product. Of course this does NOT mean they will get it but I believe they may. Just my opinion.
As far as the ATM I was half joking, but my intent was to say that if some one is willing to give them money than you would think that, the person offering the money would likely have some belief they are not just flushing it down the toilet. The company said they have over 20 million in cash now. So if nothing gets passed its irrelevant and I would be surprised if they remain viable with the limited amount of income they now have. So at the very least they need something positive or something kind of positive.
And I am hoping for a thumbs up not a thumbs down. Up is good down is bad.
I feel that if the FDA doesn't approve Zoptrex, they may want more info on it, delaying it and dragging us all along. Or they can just say yes. woohoo. Or no even though we love the safety profile of your product we don't believe there is enough proof that it is actually making some people better and keeping some people stable. That is what we have to wait for.
Which is why I am banking and hoping that they can get an approval on Macrilen because even if Zoptrex isn't a yes, Macrilen within a year or two can produce 50 to 100 million maybe more, annually which would keep the company going and viable until they can maybe get zoptrex approved or find something else. I feel they need to turn the corner now or they are in trouble.
Just my 2 cents on it. I do own stock and I am very nervous, like many others, while I wait to see what the next week and then month brings.
Good Luck
You seem to be right in your time line for possible FDA results, and top line results and pretty much what you said. But like me and any others you are nervous because the stock price goes down not up while we wait and all the nay sayers are piling on telling us how the company and Dodd are no good.
So like you, I, and many others have merit in there nervousness. Its hard to be strong and wait. There is definite risk here. Its a bio pharmaceutical company that hasn't done a whole lot (like many other bio companies) right as of yet. But what makes this situation different in my own personal mind, is you will know very soon for both of the products they are hanging there hat on. If the first one is positive though it is smaller in revenue potential I believe there will be a big spike in volume and a good bump in price, making it a lot easier to wait and see about the second event (Zoptrex). If the first goes the wrong way like it did in January you will need big massive rock hard balls to hang tough.
I sure hope Macrilen gets pushed through. Like I said before I believe it has a higher chance of success than Zoptrex. Off course I hope they both go through. And the fact they were able to secure plenty of money kind of makes you think why would someone give them the key to a 50 million dollar safe if they felt the company was about to fail miserably.
So why does the stock price keep dropping. That is the 50 million dollar question and the nay sayers will tell you its because this company sucks and will fail miserably. Me I will hang tough and see what the next 8 days bring. Fingers crossed
Good Luck
I understand what your saying and I kind of feel the same way. But isn't illegal for friends and family to be buying on insider information?
And isn't it possible they just don't know what the FDA is going to decide. Maybe they believe in their hearts it will go there way but that doesn't mean any of it will.
Maybe they are sitting on their hands waiting just like us, and the shorters continue to do what they do and that only makes you me and anyone on the side of good results more nervous.
Just two guys shooting the shit here is all. If Macrilen gets shot down by the FDA again then I personally would be very nervous and it would be harder to hold, but if it passes then I believe the stock will get a nice bump and any decisions would be easier to make. I personally think they have a better then 50-50 shot of getting it through. We'll see in a week or two most we will know.
You know the Q is gonna suck so you will have to be strong.
I agree with the assumption that if the FDA approves Zoptrex for endometrial cancer, then it will very likely pave the way for the same drug to get approvals easier and sooner for other applications as well.
The share price thing is really all conjecture. And the history of this company isn't great.
For me right now I would very much like to see baby steps, meaning lets see if the FDA overturns there original denial of Macrilen. Which they will only do if they agree that there is enough positive evidence of this drugs capabilities while over looking the fact that it narrowly missed an end point. Believing there is enough good with the ease of testing the safety compared to the ITT and results of test that are as good or better than the ITT. I feel if the first domino falls in the way of the company giving them a real revenue stream then it will be easier for the next domino to fall there way.
Just my two cents. Obviously we all know that Zoptrex has the much, much higher ceiling and the FDA seems to really like safety, and the fact that this appears to have a great safety profile it could help along with gov't supposedly looking to ease approvals.
As far as dilution I personally hope that if Zoptrex does pass the European company that AEZS is supposedly in negotiations with will supply an upfront payment large enough to fund bringing both products to market. Whether that is a likely scenario I don't know. But the company did say they were in negotiations and wanted to wait for results as it would put them in a stronger position.
Of course it could all the wrong way and we're all phucked. except for the nay sayers and shorters who will be in full force saying I told you so. Either way we will know within 30-60 days the whole truth of it.
Fingers crossed
End of the month for Macrilen and next month for Zoptrex
I agree it was good news. It means they are now exploring using Macrilen for pediatric applications which could double or triple the potential.
But its all window dressing IMO until the company gets FDA approval. Which they now say the type A meeting with the FDA is scheduled for later this month. If they get the go ahead then I believe you will see more than a blip of activity. But it seems share holders here are a very wary bunch, who are used to disappointment so they need to be smacked in the face with some success.
We will know a lot more in a short time, good luck all
Jiminy:
You asked about when FDA approval is expected not P3 which is what appears to pertain to this F-R rule which means absolutely nothing (except as an indicator of probability)
According to the company they expect to hear FDA results (positive or negative) for Zoptrex in April. According to Dodd per last weeks meetings in NY they are in negotiations with at least one or more potential customers in for rights to Zoptrex (but feel its in the companies best interest to wait (for positive results to get a better deal) for the FDA.
Also, their other product they are hoping for an FDA reversal on Macrilen they will likely have an answer from the FDA in March. It missed by a very small amount on the original attempt and I personally believ will get passed this time.
Hope this helps
So according to your indicator this has to go to 25-30 bucks before the FDA decides on Zoptrex. I hope you don't own any if this is what your expecting. I do own it and I would be shocked if that happens. Pleasantly mind you, but shocked.
Right now I am hoping for an FDA approval on Macrillen to give it a nice kick start. But I don't see that making this do more than a double to triple.
The company said at last weeks meetings that they had more partner(s) for Zoptrex, but were feeling it was in there best interest to wait for an approval as it would make it more valuable for new European partners
Its all just talk until we see what happens next
B
Well according to your F-R predictor than this will fail. Not because of the merits or faults of the product but simply because of the market cap of this company being less than 300 million. But yet you say the stock will rise to whatever if the F-R is positive. And there hasn't been one positive result with a small cap company. So I am not understanding what you are posting?
Can you further elaborate.
The time line is approximately 30 days. Whether it will now be approved is still up in the air. But if the FDA felt Macrilen definitely isn't worthy of consideration this wouldn't be taking place. They wouldn't waste their time. But Macrilen came very close to passing FDA protocols the first time through. And after considering the companies data and the fact that Macrilen does seem to be a much safer test than the Insulin tolerance test. It is very possible it will pass.
The fact is there is a market for this product and it is a safer and easier test to administer. So who knows, especially with the fact that under Trumps new regime they want to ease FDA standards a little. Maybe it will all help to push this through.
That being said even if it does go through its not going to send this to the moon but this company needs to catch a break and start producing and earning and this could be a nice kick start.
I do own stock and I am not trying to pump it in any way, just what my DD tells me. I am very hopeful with what I heard in todays release. Way more than the company peddling its ware's at a few NY conferences this week.
Just my 2 cents
That's all true. But what could make it different this time. Is after 5 years of trying to perfect this new drug. All the trials are done. There is a pretty good amount of data that appears to be positive. There are four reputable companies from around the world that appear to believe this drug has the potential to save lives and make them money, that have partnered with AEZS for rights in there markets. And there is clinical data that imo is not made up. Is this data enough to gain approval? I am not sure of that, but it does have a place in the market and if it truly saves a number of lives of people who are very sick with little other chance of living longer, with a much safer profile than doxorubicin than I believe there is a 50-50 shot for us as shareholders to cash in on science. If this crappy management team doesn't f--k it up. Its up to the FDA at this point.
And the fact that we will know good or bad very soon, makes the gamble worthwhile for me at least.
I love your blind enthusiasm. JAZZ has EPS over $5 a share. AEZS does not. Now don't get me wrong. I am hoping really hard that it does get approved, but history from this company tells me its a 50-50 gamble at best. I am taking that gamble because I believe the payday will be substantial, but not like JAZZ. If it gets approved and goes to 15-30 I would be thrilled. That may be possible IMO. Or it could fail in which case a buck may be the new number yikes. Balls of steel and brains of mush, waiting and hoping.
Good Luck
Jhonny a week ago you were saying the same thing at .80. Somehow it managed to push through that. Obviously it's a long hard climb, but volume has increased substantially in the last week or so, so maybe your wrong and its not going back to the .50s. I certainly don't know where its going, but I do see them getting some agreements done, and that is a positive sign.
I guess with what it opened at and all the day trading that probably took place it could have been much worse. Only lost about 5 grand what a day for mush brains.
I also listened in on the conference call though I missed the first 5 minutes or so and I have to say the analysts who asked questions at the end should be shot. They all harped on technical info that the company didn't have answers to yet and in the end if Macrilen is a failure who gives a rats ass about. I mean I guess if I was going to be tested for AGHD it would matter. And it didn't seem to fail by a lot but fail is fail. So for now, All I really cared about is What happens to the company going forward if Zoptrex fails? Do they go out of business? I mean they don't have much else in the pipe line as I see it, and the two drugs/tests they have know don't seem to be generating much income, so how will they survive if they had to borrow money to pin there hopes on Zoptrex. So cash flow will be a paramount concern.
In the end if Z some how manages to pass we are all going to be happy, but losing the cushion IMO that would have sustained stock price and the company puts us and them in a seemingly perilous position.
I think I need to see the company find another customer for Zoptrex, in the next two weeks, to make me feel that this new customer wants in before the price goes up, to make me feel more confident about it or just some positive news at least. Not just silence. Silence is not golden.
Just my opinion anyway.
Balls of steel or brains of mush----??????????
Because the FDA did not approve Macrilen.
Thanks for the kind words. I have been licking wounds for a long time. And on rare occasion cheering. But I do feel a little like an idiot because I did think this trial actually had the better shot of getting approval. Now what? Do I try and put a better spin on Ziop because they actually (or supposedly) have signed four companies that have done DD and they believe the product is viable with a good market. Or is it doomed to fail because this company sucks and can't get anything right?
Questions to ponder as I wait to see how crushed we get tomorrow and the next few days.
Thanks
Balls of steel Brains of mush which one will win out
Great post and excellent points made. Like playing holding em, this is gambling. And the fact is that Macrillen is a test not a drug per say, so IMO it does have a more likely chance of getting approval. Especially since there is nothing like it and it appears to be a great improvement for what is out there now. That said I haven't a clue how tough the FDA is when passing a product. But if you were ever going to take a shot at a pot odds play, at least right now you may have a better then avg shot of getting lucky, especially given the fact that you will know what is going to happen for both trials within 2 months. If these products both get approval there might finally be real institutional players coming in.
And to me even though it may have nothing to do with the future this company has been to incredibly high stock prices 5 years ago. I know this really isn't the same company, but with the low float if this really becomes in play it will not be hard for this stock to really make a nice move and for those with the balls of steel and fortitude there may be a real shot at the brass ring.
Also great point Joe, about not gambling money you can't afford to lose.
Happy new year all and good luck to all
I either have balls of steel or brains of mush, but I wont live and die with every day of up and down stock movement. I won't say or believe that when it goes up .40 it means we got it and when it goes down .40 cents we didn't. I will be surprised if Tuesday brings anything different than the last few months have. But good or bad I do think we will know soon. And I have a lot more on the line than Joe. I only hope if it isn't good news it doesn't totally crash and burn. Fingers crossed, but used to disappointment.
Happy New Year All
So what does that all mean?
I have no clue?
Thanks