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She's been the best thing to happen to AMD in a long time. Ryzen should continue to be the leader for the foreseeable future. She said last year she was gonna "make this company a lot of money". I believe her.
Earnings miss and guidance from NVDA today definitely doesn't look good for holding AMD through tomorrow. I have to think that EPYC sales and market share number is all that matters though, not sure NVIDIA problems would affect that too much. We'll know soon.
Incorrect!? Where did I say safety issues? I said this was not part of the process that was expected. We have no idea what or how long the FDA will take. The CMC and halt are not just "part of the process".
You twist and add stuff non stop to what people say
And, this “hold” is part of the change request process that they initiated, nothing more.
Sorry, but halting enrollment and asking for additional cmc information is not just "part of the change request process". In the end it could be nothing, but this was certainly not expected.
This nightmare never ends. Strange hold by the fda nonetheless.
FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our proposal to modify the AIM2CERV trial’s analysis plan
I wonder whats new that they found after already reviewing it prior. Maybe we should have just left the trial design as is.
LOL - brilliant. Never thought of the r/s as a negotiating tactic for BP to pay up. I guess it's all part of that "psychological warfare" happening in board rooms across the world fighting for LM tech.
I'm now enlightened.
I know they released data but it also wasn't far enough along to make a definitive call on it. I'm not holding my breath, but any data at this point could help.
Has the company ever discussed going piecemeal with NEO? I thought NEO was it's own product and it couldn't be split up like an off the shelf product can.
He can read your emails all day, Merck will say whether they want to make that deal or not. If PSA data is what they're waiting for before they pick up our P3, than you got me. Axal has been our lead product for years with no success in partnering.
My biggest concern is over NEO costs and whether we continue to fund it. They've blown through countless sums of cash and acted for years like they would have cash coming in. NEVER HAPPEND. We're BROKE.
Some of the science people here also say don't expect much from a P1 either. It's not far enough along to expect anything that's a blowout, which is exactly what we need to move this stock.
They need a deal. It feels like that's the only way we can prove to the market that the science is in demand.
Yeah - and that implied value was also a 35% haircut off the trading price at that time. It was actually a bigger haircut than that depending on how you wanted to value the associated warrants.
Financing will be toxic regardless of the R/S, no?
It is unfortunate that they decided to bail instead of finding a solution to the problem, as you just mentioned.
They have to partner NEO very soon given the costs, that's just a reality. Lets hope they're not reckless enough to continue it if they don't have someone basically lined up to pick up the costs...
I completely agree with you. I'm fine with them falling off the Nasdaq and showing that the science is in demand and data is good. Their funding will be terrible regardless of the r/s. It's just a matter of how fleeced we'll all get (LTSH) if they do choose to r/s and maintain authorized share count as is.
At this point in time it's safe to say that they [management] may actually be that "crazy negligent."
Just look at their history with spending. It's asinine.
I'd rather they just fall off the Nasdaq. A r/s doesn't solve their problems. The nasty financing they're going to get will be bad regardless of the reverse. I say let them show data etc before they do a thing.
Better yet - sell the company. They ROYALLY screwed up this whole process.
Ok. Thanks, Dew.
With NEO and the entire trial now in question, I wonder if HOT is the last great hope..
Of course, which is exactly what you've been saying all along. It's all hope and nothing more...
Now, what do the facts on the ground tell you? Amgen just bailed, pulled EMA, almost dropped AXAL, have not secured a single partner in years, 3 CEO's in a couple years, gave away HER2 to charity, cut workforce by nearly half, 50mm/year burn w/30mm cash and a 20mm market cap. I mean this could go on forever...
It's as if you don't believe looking at the facts on the ground matter at all. I don't get it. At some point they'll have to partner or go out, what deciding point are you waiting for? Boom or bust with HOT interim data??
I agree. The hardest part is accepting the reality that maybe, just maybe, LM isn't what we all thought it was. It's a fair question and one we need to grapple with.
The market and BP are now clearly on the sidelines. Amgen leaving was kind of the nail in the coffin for me. Keeping this thing afloat at this point, without the help of big money, seems like a fools errand.
I hope tomorrow sheds at least some light on where and why we don't have a partner and what will be done now that Amgen is gone (who's paying for NEO?). It's not looking good.
From the additional proxy soliciting material (defa14a) just filed: We expect that ADXS-503 [HOT NSCLC] will begin enrolling patients in early 2019 and anticipate having safety, tolerability and immune correlative data in the first half of 2019.
Is getting data first half of 2019 even possible? Or is this a typo on the 14a filed note from Ken?
Schedule we prefer? You mean before BK?
I think the difference is some would take $.50+ per share today, as opposed to diluting the company to oblivion tomorrow in order to postpone the shutdown a few more months. They burn 50mm a year. If they don't have something very close, I see no reason for this company to continue as is, especially with Amgen now gone.
Reverse-merger seems like a rational possibility as well.
They'd rather keep their paychecks, benefits, healthcare, job than sell the company now. They'll hold out as long as possible as they really don't have much to lose. The shares and options given to them are only bonuses if the company makes it big, they'll also replenish themselves as they always have after the reset.
LTSH are not their priority, and in a way, I understand. This is my second wipe out from this company. It didn't matter much the first round because I didn't have enough to get irate over it. I added after the NEO announcement and HOT. Still have nothing to show for it. I'm an idiot.
Spot on! The market worked as intended and now everyone is calling foul. No one here can argue that the capital was used efficiently because it wasn't. So the company got cut off from the market and cheap money.
Now, is it slightly overdone at this point? Sure. But the market worked as intended and no one will trust this company until they can prove the science is desirable and they've changed their ways...
A 15 million dollar company with 30 million cash should not be operating all of those indications on their own dime. My oh my how did they get so far out in front of their skis.
I hope Ken has something lined up for next week. I dont see how they can continue running things this thin....
I'd even take a deal for 1 billion yen at this point...
Ahh. Good point, Bomba. I was still going by what was said earlier last year from the shareholder meeting (I believe it was bourbon) that they were extremely pleased with their progress/relationship with amgen. I suppose 6 months can change everything.
Yes, except he did an about-face on AIM well before the Amgen bombshell announcement. Let’s see how hard he pushes AIM on the next cc.
How are no insiders buying down here?! Not one open market purchase when the company was trading for almost 10 million bucks.
Either insider info is holding them back or they're waiting until the R/S and dilution is over.
What does the annual meeting and patient dosing have to do with any of this? They can announce tomorrow that they're being acquired.
Agree. They will need to find a partner ASAP for NEO to continue. Plus with HOT supposedly starting soon (where’s the pr?) they won’t have the funding to complete any of it. Amgen bail, for whatever reason, was horrific for this companies strategic focus on more data going forward.
Maybe the reverse-merger being touted here is the answer...
What data do you speak of arriving in March is capable of catapulting this stock up 40x - 80x it's current valuation.... PSA, canine?
This company is going on almost 2 decades now . Just saying.
It does appear that way when you look at everything that has transpired. I mean what the heck happened with doc!? We haven't gotten answers to anything. If you look at it at face value it looks disgusting and the biggest concern for me was the amgen bail. That says plenty to me. But I'm down so far it doesn't matter anymore..
I totally concur with you on that. Unfortunately, I have a feeling it's the latter instead of the former. This is also not the first time they've neglected updating information on their website, it just seems to be getting worse.
I'll continue to hope it's the first option as well.
It's kind of pathetic that they can't keep the most basic stuff in order. I know it seems small, but as you say, that 'who cares' attitude is not the kind of attitude you want at a company in this situation.
Oh well. Who cares?
It's so outdated at this point and certainly doesn't reflect well on the company. It's not that costly to update it either.
I suppose they'll update it once they have something to say. Which also doesn't look great...