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I recall Shushi mentioned earlier today, that he doubted data would drop prior to this month's opex (June 18th).
With no change (that I'm aware of), towards the thesis of data prior to ASM on July 1st, (and assuming Shushi is correct) that only leaves a NINE business day window, for data drop!
Seems a bit tight IMO, considering the opacity of the processes in question?
Hopefully, the thesis holds!
Correct me if I am wrong, but isn't the fact they're having final results "double checked" by an outside entity, a new thing?
It's certainly the first I've heard of it.
Also (thinking out loud here): Does this imply that Cel-Sci would by definition, get to see the final data (as presented by ICON) BEFORE handing it off to the third party for verification?
For all we know, they have it now, and have chosen to define "having it", as being double checked first?
Regardless, in my mind it's either so good it needs a second set of eyes, or it's a bit "fuzzy".
I truly hope for the former!
Good luck to everyone :)
I think that site just grabs dates off the FDA Clinical Trials webpages, and mindlessly creates content.
From my understanding, as Multikine's phase 3 trial began prior to 2017, the "final rule" doesn't apply and CVM can report data whenever they like.
Not that most applicable sponsors follow that rule anyway, LOL!
Looking forward to your divinations.
I'm thinking it's something to do with the warrant extensions, and the potential shelf registration expiry (or renewal) dates?
Whatever it is, I'm intrigued!
Have a great weekend
Ahhhh...
August 3rd 2018. S3's are only valid for three years.
So, if they don't file another one by then, the shelf registration will expire?!
20,000 shares if fully exercised, at $13.75 each.
What I find interesting, is why other warrants expire dates were extended, and these ones weren't.
Perhaps THAT is the real nugget here?..
The series ZZ warrants expire on May 18th..
While I'm here, I was wondering what you all think about data being released, by May 15th?
Reason I ask, is that (from what I read on the FDA's website), trial results are to be shared with the FDA within a year of "Primary Trial Completion".
"Actual Primary Trial Completion" is listed as May 15, 2020.
I've not seen anyone mention this, so either I am misinterpreting it, or this simple fact has been hiding in plain sight all along?
Good luck to all us longs, and every person who may benefit from Multikine!
I wonder if that's a question that Gavin can answer?
It doesn't seem like something that'd be a secret; it's just a trial protocol question, and should be a publicly available item IMO..
Cheers
I also noted that in none of the news releases, regarding their recent financing, no mention of waiting on the 298 "events" was made, either..
This is a great question, one that I have wondered, myself..
I'm thinking it could, due to the increased manufacturing consistency?
Sounds like they're dropping money into expanding manufacturing capacity, as we speak!
If THAT doesn't scream confidence, what does?
They're proactively gearing-up, to meet anticipated demand!
Wow.
I have been wondering myself.
Best I can theorize, is that Ergomed is a relatively "safer" play insofar as investing in CVM's potential success. Because Ergomed is a relatively successful company in its own right, failure of CVM to deliver isn't a complete wash; you still have shares in a good company, either way.
I also feel that Ergomed's stock is harder to manipulate, for similar reasons. Therefore, if individuals/companies are bidding it up based-upon CVM's success, it will stick (in the short term, at least) because it has solid, underlying fundamentals that no short would dare bet-against, based on CVM's outcome alone. Too many other variables, working in Ergo's favour, and against that particular kind of focused shorting.
All just my opinion, but that's how I see it..
One thing I just noticed, regarding the Ergomed slide which indicated the "96%" complete info..
Am I correct in noting that all other information contained, within that presentation, is as-of JUNE 30th??
Therefore, how sure are we that the 96% figure is actually current?
Perhaps, we are much further along than we are assuming..
Thoughts?
I would think their strategy, is to help woo potential new investors, or even those potentially considering a "buyout".
Personally, I don't think it would be in CVM's best interest, to terminate the study early; no matter how good the data!
The studies end-point is 298 combined "events", period.
To terminate prior to this, is to undermine the very validity of the study.
The most statistically critical data, will be towards the END of the study. Every day longer taken to 298 "events", adds an increasingly disproportionate statistical weighting, to the overall survival stats.
That said, I think they simply needed something to reassure investors with, that nothing negative is happening here..
Just my 2 cents :)
Agreed.
It appears Cel Sci only began publicly announcing IDMC recommendations, once full enrollment was achieved in early December, 2017.
Since then, the IDMC has met roughly every 7/8 months.
I am assuming they met much more regularly prior to Dec '17, but this was simply a part of the study protocol, so not worth reporting (ie, if the trial is still ongoing, they are still letting it continue).
Unless they have to meet, due to the trial being labelled as "expected completion in September 2019", they may not meet again till October or even November, given their prior patterns.
JMHO.. :)
Makes sense.. no news, is good news here I guess, until we know otherwise!
I hear a lot of chatter (and expectations) about the IDMC meeting in September. That said, I cannot find any real proof, that this is the case.
Or, put another way, is this really more of an assumption/hope, based solely on past meeting patterns?
From what I have read (IDMC's own regulations), it seems the committee meets four times a year when the trial is actively recruiting/treating patients (every 3 months).
However, no patients are actually being treated at this point, so do they meet less frequently? (They are simply monitoring "events").
Also, the "September 2019" trial end date on the FDA site, wasn't that really an "arbitrary" date that CVM set, several months ago? (because they "needed to fill-in the blanks, on the FDA update forms"?) Paraphrasing here, but I swear I recall someone posted that was essentially what Gavin said, regarding that.
I guess I am just hoping a lot of new investors (or even seasoned ones), won't be disappointed when/if October arrives, and there's neither 298 "events" yet, nor any IDMC recommendations.
Not being negative, only trying to separate fact from assumption! (I am long, and have been in this stock for over 10 years).
As far as I am concerned, more time means more effectiveness!
Just my two cents. :)
I notice there are calls for $17.50, in December 22020!
That to me, looks very tempting..
Possibility they COULD be fully approved, by then?
Thank you for the feedback, and I like the idea of hedging via puts, as well..
We all want this to "rocket to the moon", but nothing is ever guaranteed in life (and especially CVM lol)!!
Cheers
Hi all,
What are your guys' thoughts, on buying call options on CVM? (say, six months or more expiration dates).
I'm starting to think it may be a great way to try and take advantage of any potential future price appreciation, without laying-out a large up-front investment.
I am already in it "boom or bust", so I'd rather lose a few hundred dollars on an option, than a few thousand, on actual shares!
Also, if for some reason I need to sell my existing shares in the meantime, I still have an "in" with the options..
Hope you all had a great weekend :)
Wow, I didn't realize that the dosage regimen in phase 3, was so much increased in frequency, and length of time!
This is a HUGE deal!!
I have another thought here, based on this "new to me" info.
Perhaps Geert's long-term plan, is to make Multikine THE Standard of Care! (whereby, the current SOC is only used IF Multikine fails to cause any measurable response, after 3-weeks)
That is, he is gradually "inching" towards "Multikine SOC", within the current boundaries of accepted SOC, and treatment ethics.
Argument being: If 10 days at whatever dosage did "X%" complete tumor disappearance, and 3-weeks in phase 3 did "X%+Y%", let's do a study where we give Multikine for 5-7 weeks (or longer)!
Imagine if the data suggested that could cause say, a 25% complete cure rate? And, all the while, showing that delaying current SOC beyond the current 3-weeks (for those having complete tumor disappearance, or shrinkage responses), would NOT be unethical?
Or, maybe I am just daydreaming..
Greetings, fellow CVM longs!
I've been holding and buying shares in Cel-Sci, for longer than I care to admit (since about 2007!)
I don't post a lot here, but I do regularly read and follow the board, very closely. I am grateful I bought more shares at around $3.10 recently, prior to the current run-up; so, I'm just over my break-even point, reverse-splits and all.. :)
Long and strong!
Anyway, I have been wondering something for quite a while now, and wanted to bounce it off my fellow investors.
Of all the variables affecting the outcome of the phase III study, there is one thing I have not heard much (if anything) about, and that is:
What might the impact be of the cold-fill Multikine manufacturing facility, on the effect that it has on phase 3, vs phase 2 results?
Whilst the biologic properties & chemistry of Multikine are identical in both studies, the consistency and quality of Multikine should be FAR superior in the current phase 3 trial, as compared to phase 2.
Is it out of the question then, that this improved product quality could potentially be MORE effective, and exceed survival rates observed in phase 2?
Thoughts anyone?
Have a great Easter everyone, and good luck to us all! :)
An interesting article I just read, regarding immunotherapy.
Here's the link:
https://www.medicalnewstoday.com/articles/amp/320786
It's from February 1st of this year, so my apologies if this has already been posted.
If anything, it shows that immunotherapy is a promising avenue for cancer treatment. It also shows that Cel-Sci is not alone, in its quest.
I have been holding CVM for a looooooooong time. Hoping for a positive outcome!
Good luck to all
Up here in Canada our government created 'TFSA', Tax-Free Saving Accounts, which you can use to buy/sell stocks, or just put into an interest-bearing account; whatever you want. So long as you don't put more than $5500 a year into it, all gains/dividends are 100% tax free. But you cannot claim losses either.
I use that account to trade and it makes life so much easier.. I was shocked when they actually brought that into being several years ago, but it does encourage the average person to save and invest.
Anyway, all my CVM shares are held within that, so my hope is if it hits the big-time I won't have to split my gains with the Finance Minister LOL!
Cheers
..And another article..
Medicure (V.MPH) snags industry expert advisor and investors smell acquisition, up 26%
Good luck to all,
Sunpillar
Article on Medicure today..
Medicure Comments on Recent Trading Activity
Sunpillar
Medicure mentioned as big day's gainer..
TSXV 10 Biggest Percentage Gainers Mid-Afternoon: Medicure, Omni-Lite, Immunovaccine
Hi STE,
Nice price movement today, quite a jump for sure!
Obviously the market liked today's news release.. However I am unfamiliar with Knight Therapeutics.
Any idea what this agreement really means for Medicure? (or what Medicure/Knight are really trying to achieve here?)
Good luck
Hi STE,
Good to see you are still here! What are your long-term thoughts on this stock (sp and overall for company), now that they seem to be turning the corner?
I only wish I had not sold the majority of my shares at 75 cents! In any case I still have some and will hold onto them.. Considering I held them all when it went down to 0.5 cents (pre reverse-split) it should be much easier now LOL!
Good luck,
Sunpillar
Funny you should mention a reverse merger... that very thought popped into my mind last week, when I was looking at all the insider buying that Medicure execs have been doing lately.
The CEO especially, has been buying shares hand over fist on the open market for some time now (he has bought 41,000 shares on the TSX this month alone, according to Canadianinsider).
Of course, there are many other reasons for insider buying, and this alone does not indicate any reverse mergers; just mere speculation on my part.
Regardless, if this unlikely event were to happen, as Medicure shareholders, would that be a good thing or a bad thing for us? And would it be a good thing for Correvio?
Good luck,
Sunpillar
Hi STE,
Nice to see some chatter here, it's been dreadfully quiet for far too long LOL.
Do you think there is any chance that the Tardoxal trials will yield any positive results for the company? I would think a decent interim report (which is increasingly overdue) would be cause for hope..
I also note that the companies shares on the TSX were up almost 38% today, to close at 40 cents (no news). I wonder if something is cooking?
Cheers
Sunpillar
Alere Executes License Agreement with Miraculins for Preeclampsia Technology
Here is a link to the news release on Miraculins web-site:
http://www.miraculins.com/press_releases.aspx?id=167
Good luck to all,
Sunpillar
Hey Stock,
Thanks for the post, and welcome to the Miraculins board (and I am so glad to not be just talking to myself here anymore LOL)
Yes, you are correct that there has been much good news lately. The Alere announcement today is a very big step, and should hopefully mean ongoing revenues at some point in the future, a very important thing. It seems that this company is slowly but surely transforming itself into a revenue making entity, from a money consuming one.
This company just keeps setting and meeting goals. I have been very impressed by the management ever since I stumbled across this venture a few years ago. They just keep delivering on their promises.
Good luck and welcome aboard,
Sunpillar
Yet more insider buys since I last posted, Mr. Friesen bought another 300,000 shares on the 20th (on the TSX), bringing the total he's bought this month to just over 800,000. Looks like he's on his way to buy over a million if this keeps up!
http://www.canadianinsider.com/node/7?menu_tickersearch=Medicure+Inc.+|+MPH
STE, what do you make of all this buying on the open market, by none other than the company CEO?
Good luck to all,
Sunpillar
I just noticed that there has been a sudden rush of insider buying, specifically by Mr. Friesen. Between August 10 and August 15, approximately 500,000 shares were purchased by him on the open market (on the TSX exchange)..
Here is a link to the trades:
http://canadianinsider.com/node/7?menu_tickersearch=Medicure+Inc.+|+MPH
I don't know if it means anything or not, but I cannot think it is a bad thing either.
Good luck!
Sunpillar
Finally, here is a link to a recent news release from Miraculins, highlighting the fact that Alere has chosen to renew their final 6-month option period for testing Miraculins biomarkers.
Alere Secures Final Option Period on Miraculins Preeclampsia Technology
Here is a link to a video clip, from a program called "The Next Biggest Winner". They did a segment on Miraculins a few months ago..
Here it is:
www.thenextbiggestwinner.com/miraculins/
Miraculins lead product currently is Prevu. It is a skin cholesterol test that is performed on the palm of your hand..
Here is a link to the products web-site:
prevu website
First post for this new board!
Watch the video on the company shown in the ibox if you have a chance, it is very well done. Is anyone here on iHub following this company at all, or invested in it?
Cheers,
Sunpillar.