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Anybody know why Shire wouldn't file it's own NDA with the FDA? What special sauce does CLBS have that they don't? I know that CLBS has a lot of knowledge with 34+, but ?. Either the data will support a filing or it won't as far as I know.
Also, any thoughts on the news out this morning? "Remains a statistical possibility"... not exactly a ringing endorsement, but not much I can do as I can't/won't sell until the fat lady sings in any event.
So there's been steady daily selling now since mid-august, and moving into a pre-binary event. Anybody seen anything out there that would lead to the conclusion that the results in the Sanford trials aren't good? Someone seems pretty sure they're not.
My conclusion is that it's another proof that the 'efficient market hypothesis' is the biggest bunch of BS to ever be promulgated by market theorists.
Just don't see, at this point, how an investor can lose with this company. Failure of the PII T1D study is totally priced in, as we have twice the cash on hand as our market cap... so how can it go down but cents. On the other hand, if efficacy is shown, all that cash suddenly becomes very attractive to potential buyers of both the stock or the company. JM2C
About time for some good news:
Ssa, I disagree completely. Yes, PCT produced income, but actually ran at a loss. However, that's not the important part from where I sit. If this was simply a selfish cynical move by management, why would you sell PCT? Didn't make money, but always had the potential to do so, and the money it did generate they could have ridden for a decade, easy.
However, they sold... which tells me that they are very confident that the Sanford trial is showing good results and that they don't want to go find more money on the open market to finance and carry those trials to a good end. I take this sale to be very bullish, as they now have the cash they need to finish enrollment and, given the good results I believe they think are forthcoming, enter the PIII landscape in a position of strength.
Apologies for laziness. Found it. End of March.
Wasn't the quarterly due some time ago?
You mo-mo guys are so entertaining...
Trend, not trying to rain on anybody's parade, least of all my own (!), but don't forget that it's only money spent in California... which limits it to one trial site (UCSF, and it's new), and whatever Mountain View work they can directly relate to the trials. CLBS notes that that may reach $6m of the $12.2 authorized. Not complaining about a 'free' $6m, but it's not what it appears at first glance.
So today looks like there are enough sellers who bought low to meet our buyers needs without driving up the price, happy with their near 100% return in just 6 weeks. It'll finish with 2.5x avg. volume without a price rise. Good on them.
Whomever our buyer is, it seems there's a pattern here. Buy with both hands, a few hundred thousand shares, and then pause a few days while the price settles... rinse and repeat.
Hopefully they're not done!
So hbh... have you been watching, and do you like the trend? Again, congrats to those who pulled the trigger in the $2's.
Hi hbhmb:
Yes, that's such a far prettier graph that we've seen for a while, and I must note that for anyone who bought at or near the low... congratulations, you're already looking at a 50%+ gain!
However, we're going to need a few weeks... not just a day of gains just like this to bring most of us back to any semblance of health on this stock, and big rises like this without any visible means of support should make anyone wary. What's behind it? I think I understand the first bump from the late dec lows to the high 3's in early January... but this? This bio is no different than any other; it depends upon good trial processes, procedures, and results for the price to rise... or the expectations of same. Are there any reasons one would have these expectations? Other than optimism, I see none. I've read nothing. The company has said nothing. That they expanded their clinical sites could be either good or bad news, so I don't see how that fits.
Again, love the action, but... why?
hbh... looking at yesterday and today, I'd say tax loss selling. Now if we can get some good news; another nice increase in lab income, at least a lukewarm reading on the insulin status of the 19 first cohort life (if not much more!), Japan... life will get better! Here's hoping! No news in BT is almost always a drift down IME, and we've had WAY too much of that.
Re new years wishes, yes, and same to all others who have weathered... or at least taken this beating.
hbh, I forgot one other, major thing; tax loss selling.
From an article in the WaPo:
hbhmb: No, other than the usual thinly traded bio declining when it's still far from a decisive trial result. I have bought recently, although I don't have much free cash and prefer not to sell anything else. I would really appreciate a company update on enrollment... that's the major thing that can drive the price at this point IMO. Other than that, Japan has been quiet now for some time, and there should be news there too at some point. JMO. Be well.
I've wanted to answer this post for a few weeks, but been unable. In any event, this is great news, accelerates their T1D program significantly. Regarding a later post, I don't share the view that they 'chose' to manufacture, it's just that the doors they've tried to open via trials have been slammed in their face not for lack of trying, but competition from much more heavily capitalized companies moving much quicker with different technologies... JUNO, for example. Strategic retreats, while always bitter, are a lot better than total defeat. On the manufacturing front, however, they are making big jumps qtr after qtr and year over year in income from that source... and income is always good.
There's still a long way to go to get this investment back on track, but sail on. Good news is always better than the alternative.
Great find F1ash. This is the kind of news that got Hitachi involved, and the kind of science that prompted investors to pony up $21m for the rest of the T1D trial... so pass more science, hold the bs, and keep the faith.
Thanks Hope. That means the DSMB report will be out in december, not sept as i'd hoped from the local Sanford newspaper reports. Dang! Ah well, c'est la guerre. Onwards!
Nice catch Viper... Yes, great news! Wonder where they're getting the cash to fund the Colorado and Indiana sites... And that's assuming that Sanford is still paying for their sites. Hopefully someone will ask tomorrow. Also on what basis are they moving forwards to fill the full cohort, as I thought the plan was to get a green light from the 18 first... But what do I know, as I still don't know if the 18 is even filled! I really hope that all gets answered tomorrow.
Can anyone explain this. from F1ash's post?
Thanks Viper. A simpler, less informative version of what you posted last week, but welcome nevertheless.
Ah, but HBH, you knew that already. The only thing that 'moves the needle' in developmental bios are actions; trials filed and filled, results in good or bad... that's what we're here for... or at least that's what I'm here for. IMO, as apparently yours, chartists are off their own charts when they try to apply statistical laws of mass behavior to small, data driven bios. GL.
Stockace, you'll find a much more appreciative audience for your sock-puppet nonsense (prophet and checkmateseven) over on the yahoo board. I'd much rather see nothing here than read any more of your highly informed and informative posts... and take your new shoes with you, please.
Woo-Hoo!! 2 cents!!! I know I'm feeling better!
On another front, NWBO in death spiral, now under 'fity cent'.
You people are hilarious!
More than interesting, Viper; very informative. The article is dated June 10th, and at that time they state that there are 19 subjects enrolled in the study. We know that the initial subset of 18 is a proof of concept cohort:
All good, Prophet. Happy to be wrong, but I've never seen charts work in bio before. GL.
s
Prophetable, I certainly don't hope you're wrong, but I can only shrug when chartists come to developmental stage biotech. Charts are premised on the same thing that drives clinical trials... laws of large numbers. IMO they don't hold in bio-land, as small bio's are ruled by their science and the FDA, and don't have the mass market that will, over time, substantiate chart theory. However, that's just my take, and all the best to you...
goes... where?
The perils of Pauline. We just passed NWBO... that would be the NWBO that went to $12.50 when we were at $2.00. NWBO is now at .57 cents. It's a dangerous world out there.
Anyone have a clue about this move today? 320,000 shares in the first 45 minutes? Short covers?
You're hard to please, Virgil. First you complain that no one has anything to say, and now having initiated a conversation, you answer with... fluff? So what is it, Virgilio, a p-III the payment for which will 'move the needle', or not? How big is it going to be, Virgilio, because sometimes size does matter. My guess is around 75, max 100, double blind, 50/50.
Virgilio:
I speak fluent English, Spanish, and French, with passable German, and generally understand written Italian and Portuguese... so for your argument, there's no there, there, Virgilio. 25 years in the US, 30 in Latin America, and now 12 here in France where I live. Just use the spellcheck, regardless of the language.
As to your site link and the 'usual size of a PIII trial', well, that's too funny. Do you really think that a small company like Kiadis, less than one year public, is going to fund a trial the size that Novartis or Pfizer would do?
Get real. This p-III will be under 100, and I'm betting closer to 75 than anything.
For openers, Virgilio, please pay attention to your spell-checker. When a word, like mistery, is underlined, it means it's misspelled. It's 'mystery'.
Regarding your statement about moving the needle and simple numbers found on the web, please enlighten. The Kiadis contract is for PCT to manufacture trials material for a P-III trial to start in 2h 2016. However, unless you can show me where, there is no information about how large that trial might be. Their P-II trial was a huge one (lol)... all of 23 people. Now, unless you know the proposed size of the P-III, let's assume it's twice as big... 50. Given that number, I'd propose that you do some math and figure out what PCT is going to charge for those 50 doses in order to 'move the needle'. PCT gross is now about $30m annually. Moving the needle would be... what... another $10m? After all, it was you who made the case that PCT won't save CLBS, as the margins are too small on relatively small sales given the burn. So now it would be your contention that not only CLBS is going to earn an additional $10m, but that that additional profit of $1.7m will 'move the needle'.
I think not. PCT needs to become the contract supplier for a large market approved drug in order to 'move the (CLBS) needle'. Now, it's possible that this P-III might get approved, and thereafter PCT might manufacture for sales... but that's at least 3 years out at best, so IMO there will be no needle moving with the Kiadis contract.
Virgilio, I'm surprised that you'd be interested in the numbers added to the total by a small trials contract. Didn't you start here by making the case that PCT, at a 17% margin, wasn't going to save the company any time soon? That being the case, if they update to $33m in the next quarterly... how does that make a real difference to you or the company?
What's needed is sizzle, not steak... or certainly not A steak. They need at least a few whole cows to make a difference where you're looking now. Sizzle, on the other hand, could come with the news that the 18 and more have entered the Sanford trial. You know, the audacity of hope and all that...
Virgilio, I assume that people paid to do jobs generally do them. I have never known and never will know where companies I invest in are going to get financing... and am perfectly comfortable with that lack of knowledge. You, apparently, are not. If CLBS is unable to secure financing to go forwards it will only be for one reason; no one is willing to take a gamble on them and have no faith in their future. If that is the case, then my own gamble will have proven to be unwise... and it won't be the first or the last time I make a mistake. However, I'm willing to wait and see them through the 18 cohort and make another decision then. As I said, it's a casino. There are no sure bets, and worrying about other peoples jobs and problems doesn't interest me.
However, look at it this way; IF they get to a good result with the small Sanford group, IMO you're looking at a 50-150% over the current price. I'm happy with that return against a potential 10-20% drop. Again, you don't see it that way... no problem. Take your chips and go to another table. Admit it or not, we're all on the outside looking in, regardless of the name of the company.
I'd call this statement: