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well damn... just checked their website for the CC I thought was today, the 1wth, only to see its saying its tomorrow, the 13th instead at (8 AM PST) (11 AM EST)
Nov 13, 2020 11:00 am ET/8:00 am PT
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well isn't the real issue one of, why wouldn't the results be replicated??
Its a rather very straight forward trial, almost a 'go-no go' trial to a degree in that it either works or it doesn't..
and it appears easy enough to confirm whether or not it does.
Bottom line is, if the data in the trial arm is valid data, and the control arm fails to support the trial due to the current standard of care being what it is...
Not sure what your issue is with respect to them asking the FDA for early termination... Now I will agree, IF the data/effectiveness seen is questionable in that its not doing what they are looking for it to do, yeah, I would expect the FDA to say, redesign or continue the trial to completion..
But that does not seem to be the issue based on what they are indicating...
Morning...
another board alerted me to the 'news' of yesterday on this one. But this is only a PH 2, and while I have never shorted a stock, IF this thing jumps this morn in the premarket, I will be looking to buy PUTS on it.. (but the current option range isn't conducive to a good PUT trade unless they add some strike prices.. damn...)
and those with gains, as this was only a PH 2, you may seriously want to consider locking those gains in. Cause unless they can get fast tracked off this Ph 2 to approval, the share price is NOT likely to hold...
not with at least a 2 year PH 3 to run..
looking at a chart this morn in the pre market, up at $21 at the moment, but on very light volume... not a good time or price to be buying at. Mercy, seen this horror show too many times before..
disclaimer: just heard about this one this morn, a few minutes ago, enough time to read thru yesterdays news, see that its a PH 2 and having been around bio developments for around 20 years, will be looking to PUT this one. But added it to my 'watch list', going to investigate it closer, watch its PH3 development... see what its future holds.. Good luck.
Tomorrow, Nov 12th...
Will they finally say something, with silver over $24/oz to propel this thing back over $3 and rising??
Boy has it been a long hold on this one with the last 18 months being due to the damn delay in getting their water permit and then getting going..
any reason to reject the results of the PH 2 and or expect them to be any different in the PH 3?? Is 30% at 1 year, 20% at 2 years vs no survivors from the PH 2 at 2 years in the salvage arm?? Not to mention the shortened time to treatment thanks to the conditioning??
From my recall, the goal was to improve the results of not using it..
insert-text-here
In a Phase 2 clinical study in 58 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and these patients experienced transplant engraftment at day 28. The overall survival rate of the 36 relapsed or refractory AML patients in the proof of concept study was 30% at one year and approximately 20% at two years. See Iomab-B study results here.
there is this article on results published back in Feb 2019.. I have to keep reminding myself that this is just something that is designed to make something else 'more achievable/effective'... ie, if you use it, does the 'standard of care' currently in use work 'better' than it does... Unless this trial interim readout shows the standard of care currently in use is just as 'good' or that the pre-conditioning adds no value... But the prior results appear to say, pre-conditioning makes the 'standard of care' better, more effective... but at the same time, even if approved, I don't see the share price doing a heck of a lot more than $20 ($220 Million market cap)
to sum it up? Does Iomabb make the standard of care better or not?? Based on whats been reported, sounds like it..
https://www.onclive.com/view/iomabb-shows-promise-as-novel-conditioning-for-hsct-in-aml
February 24, 2019
After taking another look at the 10Q, bottom of page 17, into page 18, my take is that the trial is going well (extension of prior 'results'), but that due to the 'control arm' failing to give them a meaningful comparison (ie, so many in the control FAIL to meet a standard of expectation, its useless for comparison sake) its FUTILE to continue the trial.
So as I read this again, and based on prior 'results' as described below, I will defer back to that comment not so long ago that its likely based on what they already know, and what they expect to see, that they are expecting to ask the FDA for an early termination and proceed to an NDA submission.. (marked some in italics, some in bold, but not sure what it will look like as 'preview' doesn't translate to final view)
Safety and feasibility data from the first 75 patients enrolled on the SIERRA trial, which represents 50% of the total of 150 patients to be enrolled in the trial, was presented in an oral presentation at the Transplantation & Cellular Therapy (“TCT”) Meetings of the American Society for Transplantation and Cellular Therapy (“ASTCT”) and Center for International Bone & Marrow Transplant Research (“CIBMTR”) in February 2020. It was reported that 100% of patients (31/31) on the study arm that received a therapeutic dose of Iomab-B received a BMT, with a median time to BMT of 30 days, and all patients achieved neutrophil and platelet engraftment in a median time of 20 days despite a high median blast count of 30%. On the control arm, only 18% of patients (7/38) achieved remission after salvage therapy, and then received a BMT with a median time to BMT of 67 days and median blast count of 26%. Of the 82% of patients failing to achieve a CR with conventional care (31/38), 20 patients were eligible to cross over to receive Iomab-B followed by transplant. These patients are considered as having failed the primary endpoint of the study. All crossover patients who received the therapeutic dose of Iomab-B (20/20) received a BMT, with a median time to BMT of 64 days and they achieved engraftment in a median time of 19 days despite high median blast count of 35% at time of crossover. It was also reported that 100-day non-relapse transplant-related mortality (100-day TRM) of the study or Iomab-B arm was only 6% (2/31) of patients that received a BMT compared to 29% of patients (2/7) who received a BMT after salvage therapy on the control arm. The universal engraftment rate and low 100-day TRM rate of the Iomab-B arm resulted in 29 patients potentially evaluable for the primary endpoint compared to 5 patients in the control arm, a nearly six times difference.
17
We have reached 75% enrollment in the SIERRA trial. We expect to present safety and feasibility data including rates of BMT engraftment, 100-day TRM and key safety metrics from 113 patients, representing 75% of the planned 150-patient enrollment, as we did on the first 25% and 50% of patients. In addition, rates of CR and rates of patients that did not achieve CR who then received Iomab-B, defined as failures for the primary endpoint, will be reported for patients randomized to the control arm.
The SIERRA trial is powered to show a two-times difference in the primary endpoint of dCR at 180 days at full enrollment of the study. The SIERRA trial design allowed for up to two ad hoc interim analyses of the primary endpoint exercisable at our discretion and triggered by an enrollment range of 70 to 110 patients. We exercised a single ad hoc interim analysis in the second quarter of 2020 based on the data reported from SIERRA thus far that is consistent with prior findings with Iomab-B and have updated and shared the updated SIERRA trial protocol and statistical analysis plan with the FDA to reflect the single ad hoc interim analysis. With a single ad hoc interim analysis exercised, the final analysis on full enrollment of 150 patients would be conducted with a p-value of 0.046 defining success of the trial. The interim analysis is expected to be completed in the fourth quarter of 2020 and could result in a recommendation for early termination of the trial for futility of one of the arms, or a continuation of the trial. The company intends to consult with the FDA should the recommendation be to terminate the study due to futility of the control arm.
noticed the same 'change' in the outlook from early termination because of potentially good results to what you are now referring.
and the inclusion of 'because of futility'..
Because of the PH 2 results, because I was expecting this trial to mimic the PH2 just on a larger scale, I was expecting 'good' results vs 'bad results'...
Didn't get into it beyond the initial read, but thought of an email to IR to ask about the change in the language. Just hadn't gotten around to to doing it.
disclaimer: own shares, some under Nov 12.5 covered calls, some under Dec 15s. And with this drop pondering whether or not to close the calls out for the gains I could take (due to the share price slide) and resell another batch IF the price comes up, or just let them ride as is..
not surprised to hear this. The PM sector miners have been in a slide since early Aug..
Can see where now and then there is an effort to buy the dips/lift the sector, but for many of the 70 miner tickers I follow, the trend has been for lower...
kind of thinking the sectors 'momentum' has taken a temporary hiatus..
hold shares from around $2.75-2.8, that I bought in mid Aug after selling them higher (and this is after flipping shares a few times since it left the $/sh price range some time ago)
So have done well with this one for some time now... And thought of selling these as the chart started to hint at a slide developing, but was afraid they would make an announcement and spike the price up.
So been watching and figured $2.5 would be a good buy range... It might dip some more, but added today at $2.55..
Figuring $3.5 would be a nice gain, and anything higher, even better.
Would like to get $5, and suspect they will if the price of silver holds over $20, all going to depend on their 'profit margin' and rate of ramping up the tonnage processed..
Good luck...
Have an 'awareness' going on the Investor Village Precious Metal board..
And there are a couple of others that appear to own 'some' shares..
and quite frankly, my approach is to put it out there a few times, why and
let folks decide for themselves.
Biggest concern is, the PM sector has been in a slide since early August.
When AXU announces commencement, will anyone 'care' if the sector is
under selling pressure??
Cause sure don't seem to see it being 'talked' about... (ie, not one of the ones being promoted by they hypesters)..
Fully agree with you...
But again, I don't like to buy and hold based on PH 2 trials unless the data is very compelling, and with very good odds of replication in the PH 3.
IE, I don't mind paying more if thats what happens.
But I am not against trading a PH 2 data dump IF even there, the odds favor a positive result... So yeah, based on what they just said, I am a thinking the Rhett PH 2 is going to be a tradeable event..
The only question after data releases like these is, will the share price wander lower as the run to the next event commences..
and agree, IF I could get some sub $5, that would be nice for me.. If I pay higher, it will be what it is..
Oct options expiration..
lost 500 shares to the Oct $10 covered calls, but as I had gains on both the shares and the calls, ok with it happening.
So when the share price faded this morn to sub $11.9, added a 1000 more shares and sold the Dec $15s calls for $2.25/sh. Gains anticipated:
min: $2247 on the calls
max: $2247 on the calls + $3.12/sh for a total gain of $5367 for 2 months of holding... be a 45% gain...
have something similar going on with the Nov $12.5s, but not as good for a little over a one month holding.. and unfortunately, those calls are looking in jeopardy far too early..
disclaimer: only doing this because of the aspect that IF ATNM has to complete their PH 3? They are looking at Dec 2021 to do so... and yes, aware that they might have a PH 3 interim data PR in late Dec/Jan and a potential trial halt...
Had this discussion with my son who is starting his 'investing' education..
And it went, what is 'something worth' when it has no product to sell, and IF its forced to follow the existing timelines, won't have something to sell until after Jan 2022...
and the conversation centered around SAVA, AVXL and a couple of others that we own positions in. None of them have anything approved, but one of the others is getting close to its FDA PDUFA date, the other has the potential for an early halt to its PH 3, possibly know by the end of the year.
But the discussion was on how the market can price something at a $, something else making a little more noise at $5, etc... That the rationale for justifying a stocks valuation now is all over the place. Sava for instance at $10 when it hasn't even submitted its PH 3 to the FDA for consideration?? AVXL at $5, heading for $6 where unless it gets a surprise halt to its PH 3 next Q1 or Q2, isn't looking for the PH 3 to wrap up until Dec 2021..
So in that light, the shares I held in AVXL for the last couple of months, I sold today on the spike up in price. And this was after getting lucky to keep the shares as my $5 covered calls expired last Friday. Figured making 40% between the share price move and calls (around $5500) was 'good enough' for the moment. Plus, the next round of covered calls wasn't worth the effort to sell vs the gains in the share price move today..
So alas, will look to reload one of these days. See if the noise off their latest PR fades away before the next round of PR hits the street. IF not? Then at some point, I buy ATM calls for the PRs 'pending/expected'. And if I miss, I am happy with what I made so far...
To close, sometimes you just have to take advantage of whats been 'given'... Good luck... especially for those that NEED what they are trying to accomplish..
agree, could be a nice run developing.
Trying to figure out how long I will hold my shares once they commence.
Going to be interesting to see what the company's earnings projections are once they get going...
Hopefully, it will get the attention of the sector.. looking for something not already overvalued.
Nice, but not surprised its stabilizing like it is.
First as a disclaimer: I own shares...
2nd: these are PH 2s, they are tackling some tough diseases, so not surprised people are wary since the current trials being completed are just PH 2s. Much tougher PH 3s to complete. Nice to get 'excited' about the results, but very hard to justify a double digit share price off a PH 2 (like SAVA has)..
3rd: ok, they got results, they didn't fail the PH 2. Very positive. Now onto the next trials to wrap up. What is it a Rett Ph2 on deck? Then a PH 2/3 next June/July (pediatric trial??)
then the Holy Grail trial, but not till late in 2021...
to close, I am just keeping it real for myself, keeping the expectations muted simply because so many others have failed...
But like the knowledge that they apparently did 'well' with this one.. Be waiting to see if there are any published reports to scan thru as time goes on..
Good luck... a lot of folks in this world need someone to finally be successful.
don't know whats going on besides the potential for a request for an early halt to the PH 3, or is it just that the bio ETFS like IBB, XBI have been moving higher..
But going to lose some shares this Friday to the covered calls (gains on the shares and gains on the calls sold),
and if this keeps up, going to lose the shares at $12.50 in November as well (bulk of my shares)
but not a bad problem to have I guess
not all rosy tho... slide deck shows that it won't be till Q1 2021 that they start to see 'revenues' flow...
implies running flat for another month or two likely or until they make the announcement production commencing..
Corporate presentation, looks like it was used at an 'event' 7-9 Oct. 28 slides in length, and like the comment from page 4 regarding the 'higher prices' of silver... hoping this will help push this to at least $5/sh once they get started..
https://www.alexcoresource.com/site/assets/files/4453/axu_-_121_mining_apac_october_2020_meetings_-_final.pdf
FROM SLIDE 4 of 28:
A Production Promise Delivered
Admittedly A Little Later Than Expected …
And it appears we may be delivering silver into a market that is at least
50% improved versus our underlying pricing assumptions
Be nice IF the recent move is predicated on an announcement of the commencement of mining...
Topline data this qtr..
In a Sept presentation, slide 12 of 24 indicates:
SIERRA Trial Upcoming Data Events
Topline data expected in 2020 with potential for early stoppage
the danger of selling covered calls is the shares are under the calls when the data is released...
Note, in another, slide 6 of 24, they discuss the potential 'market' for the Sierra 3 trial applicability. Fortunately for folks, its not a large number of people needing this treatment. But its why I have kept my 'expectations' conservative with respect to the share price..
So to close... Q4 could be 'enlightening' given the presentation is indicating they are upbeat on the prospects. And even if they get a PH 3 trial halt, its still another journey to get the submission put together, accepted and then an FDA decision so many months later..
with what is it, only 11 Million shares outstanding, another 4 Million is tolerable at this stage.
Further, because of the low share count, I have a 'self' target of $20 on this one only because if the PH 3 is good (and I am anticipating it will be after the PH 2 results), its bound to bounce.
In the meantime, I am selling covered calls against all of my shares. Will take a $ or more/sh if I can get it while I wait even if it means I have to reload on the shares cause it spikes unexpectedly. (which works out to a 9-10% 'return' for a month hold on the shares I own)
From a chart perspective, its risen up to the current price range of $10.5x.. has some momentum, but the volume is 'light'. Almost less than the 200,000 minimum share traded/day threshold I like to observe to ensure there is enough liquidity/interest. Going to be interesting to see if it can climb over $11.
Note: hold small amount of Oct $10 strike price calls, green on the calls sold in that I could buy the calls back, keep the shares and still have profits, then sell the Nov $12.5s.
bulk of the shares are already under the Nov $12.5 calls... taking advantage of that time premium decay..
figured the drop in the share price was just part of the 'overall PM sector' slide thats in progress...
Course, wouldn't be surprised to learn the 'short sellers' are taking advantage of the moment..
Bigger question is, IF they announce commencement of mining, if the sector is under pressure, how much of an impact will it have on the PRs 'effect' on the share price??
With silver around $24, its going to be curious to see how the share price reacts IF/when they announce production has commenced and first product is ready for sale.
I'd like to think that after a quarter of production, IF silver can hold above $20, they start to see north of $5/sh...
1000 shares for the Oct OE day at the $10 strike level covered calls
2000 for the Nov OE day at the $12.5 level cc's
with the share price at $9.17/, green on the Oct cc's...
decided to take what it gives until they are taken away.. no more waiting for them to release 'news'...
plan to close out the Oct ones and then sell them at the 12.5 strike for Nov..
just a matter of timing...
be nice to see silver above $20 tho when they announce they have started moving ore...
Sure would like to see $4+ on this one SOON...
chart IF it continues its current pattern is hinting that the post re/split sell off maybe over.. and there is some positive pressure on the shares recently...
And that maybe the focus is starting to quietly shift to the pending data thats 'overdue' based on managements prior comments.
However, that said, we have to admit, this is still at least almost a year away from an FDA decision date...
so have sold some covered calls on the shares, still have some shares 'uncovered' in case they do release PR...
had 700 shares taken away Friday as a result of selling the $10 strike covered calls.
As of Thursday, thought they were going to be safe... LOL..
Oh well, made money on the shares/calls, will just have to get some more come Monday..
Yep, thought they were going to be safe, but the chart is now saying, IF the trend continues, higher prices are forecasted...
AXU put out an 'update' on their progress, state of preps to move ore..
Looking good, but not enough to spark the market interest in the shares cause it doesn't say exactly when they will commence other than 'Q4'..
Also of note is the announcement of Ocean somebody that will take the left over material for pulling out the lead and forget what else they mentioned (might have been zinc?)
FYI, got it via their investor alert service..
have to remember, $9.30 is 31 CENTS before that damn 1 - 30 move they made..
Some news, only a PH 1 tho.. but news... is this the driver for todays move?? TBD'd
https://ir.actiniumpharma.com/press-releases/detail/365/actinium-pharmaceuticals-announces-successful-completion-of
was looking for bounce off the bottom, but not, this strong, and not over $10 by Septs OE day..
(sold the $10 calls for this Fridays close)...
wonder why this move this morn???
An announcement/little PR would be nice to see about now while the price of silver stays elevated...
Who knows how long this will last...
man, talk about fair weather shareholders...
Or has everyone sold out??
disclaimer: hold as many now as I did before... just going to have to continue to be patient, and sell the covered calls when things are 'quiet' and no news expected.
Now playing ATNM for the end of the year release and if the shares I sold calls on are taken away? Well, just buy another round...
Cause the story hasn't changed...
glad 'so far' that I sold the Sept 10 calls on half of my shares..
Looks like management hasn't decided to 'share' the results of the trial interim data 'yet'...
oh well, we get to option day coming up without news? Sell the Oct calls next..
Well, needs to get a little 'giddy up and go' going on already (smile)
Hopefully they announce moving ore before the PM market decides to do a 'correction'...
and takes away the enthusiasm
First, no need to worry about defending management with me. I didn't start riding this one heavily until it was down around 20-25 cents/sh... And as far as managements actions go? If I decide to stick around with an awareness of what they are doing, then its my 'responsibility' for my decision to do so.
Anyways, share price got the hit, but finally saw a 'buy' signal develop last week (forget the day I posted about it on the IV board). At the time, I picked up around 4000 shares at $4.14, promptly sold the Sept $4 calls for a 'net' gain of 64 cents/sh if I lose the shares at $4 on Septs OE day. (this buy was purely for the gains off the calls). And as that day approaches, I will look at what I paid for the calls, what it will cost to buy them back to close them out, and what I can sell another round for (most likely the $5s if I keep the shares).
And again, if I lose the shares, I am ok with the 16% one month gain...
Good luck...
some trades on this one..
own 1000 shares bought this morn at $8.76... (what used to be 29 cents)
own another 1000 shares bought at $9.3 or so, but have sold the Sept $10 calls for 80 and 88 cents on 500 and 500 shares respectively.
reasoning:
1. that PH 3 interim which they were reportedly going to release at their 'discretion', I am expecting it to happen, but no idea when. Only reason why I feel they will is because its a pretty straight forward development they have in progress. Unfortunately, I also suspect that when they do, they may also discuss a secondary offering. TBD'd how the share price reacts overall.
2. told myself, IF I can get shares at under 30 cents, I am going to. My first re-purchase at $9.3 was to 'have some' just in case (close enough). IF I lose that 1000 shares at $10, I will have made $1500 or so on them for roughly a months worth of holding. Which will be around a 16% gain. Not too bad a return.
3. the other 1000 shares bought this morn, will be my shares to hold in the event they do say something before the trial is scheduled to wrap up late this year.
4. the chart is showing that 'some' possible support at the $8.7 level. And I say this because volume has been declining as the price has slid down to this level. Now watching a chart momentum indicator I use to see if it will confirm it or not.
5. Plan: keep 1000 shares 'free' to run.
Keep the other 1000 shares and sell calls as long as the trade works in my favor, see if I can
get away with reducing the cost basis.
at some point, the trial will end, and then they will go into the drawn out submission timeline.
Intend to keep selling covered calls during that period.
and IF the price does drop some more? Now that its under 30 cents/sh, I intend to add some
more back.
outlook: I am no longer expecting to get the 10x return I was looking for from sub 30 cents to $3. Now will settle for 2 - 3x, added to if selling the covered calls works in my favor. Now because of its 'price' being 'seen' as elevated.
and as a disclaimer: yes, its possible the share price gets clipped much lower before this is all over with...
not yet.... the 'game' is still just beginning...
IF they can obtain a market cap of $1 Billion (was achievable at just $2.5/sh before the r/split when they had a target price of $3/sh on them)
BEFORE the reverse split, nothing says they can't still achieve $1 Billion post the split.
Still going to come down to the PH 3, whether or not it passes, and then whether or not sales could justify the share price... and a $1 Billion market cap...
So overall, the share holders aren't 'screwed' (yet), its just the conditions have 'changed' a bit...
Now they start doing secondaries and issuing a lot of shares, then we have a change in the outlook..
At what is it, around 14 Million shares, a share price of $75 starts to get close to $1 Billion...
They sell 5 Million shares to raise money?? Now we are talking about a hit to the expectations.. $52/sh on 19 Million shares... $1.75 pre the r/split...
anyways, all kinds of scenarios we could run thru. My biggest concern is secondaries and its impact on the share price potential... not to mention, we still don't have a good 'sales/revenue' picture either and I will be honest, I was hoping getting to the $3/sh was going to happen before that came into play...
disclaimer: only hold 800 shares I recently bought back late last week around $9.3 just to have some in case they data dumped the interim PH 3.. and with the share price at what, $8.90, sub 30 cents again, I can't stop it from happening, so I will take advantage of the pullback to reload...
can it hold $2.60?? its tested this level a couple of times..
as an update on the PM sector, I track 57 of the 'index listed' miners.. and as of today, everyone of them is now in a negative momentum trend.
Hopefully, if this momentum continues, it doesn't drag AXU down, hopefully the price of silver remains above $15=17/oz
Going to be really ticked if this one took so long to get its damn permit, and then has a sector run develop, only to see it fall off before smeltering operations actually start.