I have been told by a former CTI employee that Bianco is not popular among FDA people, which will certainly not facilitate future negotiations.
BXLT, as sophisticated as it might appear, has lots of organizational problems right now. Given the fact that PAC has been the core product expected to make the largest revenues, I am pretty curious how BXLT will handle this situation.
Of course, I am also curious which impact BVF will have in this context. It's weird though that they invested just before the FDA discovered an increased mortality...
I'd like to hear from her directly on what exactly has happened here first. This is a huge trial involving most of the best medical centers in the US. The first interim analysis was scheduled for August of this year, only six months from now. Are the deaths directly related to the treatment or from their conditions started off with? FDA protocols dictate holds when deaths occur. I fully understand that. What troubles me the most is why take the application off and why isn't there any statement by her on behalf of the company now? I've seen holds before but the companies often react quickly to assure investors. This lack of statement by the study director is adding fuel to the whole suspicion. Shouldn't she make some statement here???
In keeping with my last email, it does open the door to the possibility that CTI really hasn't had a chance to discuss the data with the FDA and a competitor was successful in spooking the FDA. This stinks of some type of hit job.
I don't know the best path ahead. You would think that CTI would be able to make a strong case when they meet with the FDA. Earl could be right that a black box may be what happens here for patients with very low blood platelets with perhaps lower doses. It does sound like there was a dose connection.
Anyway, I'm just trying to figure out if any of this can be salvaged. I find it hard to believe that a program can be killed so suddenly without super strong data clearly linking cause/effect.
And on this note, and it's a weird question, could you file a lawsuit against a competitor if they slandered your company/data and caused the FDA to completely change course?
The only silver lining that I see here is that BVF is stuck in this too and at least they have a lot of skin in the game and have a BOD seat (and will get another). It may be that the best path forward is trying to sell CTIC off. I actually had hoped for a buyout earlier as I really don't like holding through regulatory review periods. I've been burned before but never as bad as this....
Sad to hear of trial deaths, that brought to my attention the Bianco Boys. Links don't work as the songs themselves aged out of the system, but nevertheless in the past an entire double album was created, as a "tribute" of sorts, to destruction of wealth and lining of pockets.
Doesn't it surprise you that BXLT expanded into so many other indication if there was a clear safety signal?
I'm really struggling with this. BXLT is a sophisticated company so why did they jump all over this opportunity and then aggressively expand the potential indications. It's really difficult to understand. This was sort of like the ultimate tease since CTIC was allowed to file with only one trial and then the FDA does a complete 180 and kills the program. This brings me to another point that I recently discovered. CTIC filed a prospectus on 12/4/16. I think you will reach the same conclusion as me when you read it. It sounds like a CTI competitor openly challenged PAC's safety and efficacy and this may ultimately be why the program was halted. It's hard to know, but clearly some fight was going on.
In it was disclosed this:
On December 3, 2015, we received a letter from a potential competitor for pacritnib dated December 2, 2015 alleging, among other things, that certain oral statements made by us regarding the safety and efficacy of the potential competitor’s drug and pacritinib were false or misleading. The potential competitor has demanded that we discontinue such messaging and take appropriate corrective actions to remedy those statements. Based on a preliminary review of this letter, we believe that the claims in the letter are misguided and that the letter was motivated not out of any concern regarding the safety or efficacy of pacritnib but rather for competitive purposes. We intend to respond to this potential competitor in due course, indicating our strong disagreement with the conclusions drawn in the letter.
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Over the years, CTIC has had so many reverse splits, that if you owned 10,000 shares at $1.20 share that you paid $12,000 for, that after those reverse splits, that $12,000 investment would be worth exactly $10 today,
With that type of performance, only a lunatic or complete idiot could think that CTIC is a worthwhile investment.
If they knew it would be disgusting on a level that I'm not sure one could stomach. This brings up another whole topic.
When they raised money they did so at 1.10 and 1.25 primarily. One of the largest investors was BVF and they now have a board seat so they are in this thing too. You may remember the strange trading action when BVF originally came in at $1.57 and then again heavily at 1.10. Lots of insiders were selling heavily at that time including BOD members. It was an ugly situation.
What I do know is that those were preferred rounds but the preferred converted to common as I recall. Did you follow this at all?
I remember that all of the long term performance awards were replaced with new options with a 1.24 strike for Bianco. He also holds 2.26 million shares (or around that) so his skin in the game has narrowed drastically.
Certainly the agenda for all involved is to get as much money out of this as possible. One would assume that BVF is the most damaged here since they own so many shares...around 44 million or so. BVF is an activist investor or so I've heard. What do you think their next move will be?
I'm assuming their N1 or N2 preferred shares have largely converted to common, but it's impossible to get this information. If they are largely exposed (and stuck with common) then it stands to reason that they will push for an exit.
One has to wonder if CTI can be sold off. PAC was the obvious lead asset but there is a pipeline (even though many here don't seem to think much of it).
What do you see happening?
Do you believe that Blackrock was one of the investors in the recent preferred rounds? I'm just trying to figure out when they invested and at what price level.
Well talk later honey boo boo, got to run...absolutely darling... Now just stop it already !
X & O's....To the moon and back....Toodle Lue