What was the point of doing all of that data anaylsis before meeting with the FDA? At some point, they should have to give us a detailed account of what went down in that meeting and what they were trying to acheive.
If they didn't push for approval without further studies, the time preparing makes sense. If not, how in the world are we 1 year out from the CRL and the trial hasn't even been approved yet?
As long as we're wondering why Titan/Braeburn took the route they did, why six months? The earlier trials already showed the implant lasts that long, and duration doesn't seem to be in question by the FDA. So if all they're asking is to compare the maintenance effect between it and 4-8mg Subox, seems like that could be done in a couple month trial. Sure we'll never know.
It's pretty tough to understand what Titan and Braeburn have been doing since the CRL. But Braeburn has the control and the money and Apple Tree doesn't appear to be very tolerant of misfeasance. As someone has suggested eventually Titan needs more funding and the longer the process takes the more money Titan needs and the better the opportunity for Braeburn to buy more shares at a lower price.
The pps went to .32 after the CRL. If Zack's is right and approval won't occur,if ever,until early in 2017,Braeburn could be in the position to buy several million additional shares at .50 or less.
As far as I can see Jon (nowak488), there are many reasons not to trust this company. As you are no doubt painfully aware, I base this on many years of watching them daily, along with the extensive research I've done, as you are also very much aware. Just as with Deerfield and Oxford Capital before it, Braeburn has enjoyed quite the 'sweetheart' treatment by Titan, very much at the expense of Titan's shareholders, just as in the past. All manner of explanations can be made (and so far many were made by them, some even plausible) but Titan's results as an enterprise remain clear. There are none. Not really. And it now looks as if Titan's setting its pal Braeburn up for a nice discount purchase price, at the very great expense of current shareholders. Sorry pal but if it "looks like a duck..." Getting private investors to pay for Fanapt, then shuffling it off the books was shrewd, as have been every one of these "stories" so far with Probuphine. In fact, as you well know, I attended the AdCom in MD in 2013 and like many here, I too once bought their "story." All these years later I say, "that was then, this is now." It's not far fetched at all to ponder what's happening here, once one removes the "power of their presentation...the "I want to believe factor" and simply looks at the facts. In my opinion, regardless all the rest, one would be wise to consider that this company has been in business 20 years and has completely wiped out shareholders before, so it shouldn't be all that curious when it happens again. Consider too the market environment's near total lack of regulatory oversight or enforcement, the potential consequences for malfeasance, and basically theirs is a license to steal. After more than 5 years of watching this company daily, it's clear to me they have no intention of sharing profits with any public investor. While mine is but one person's opinion, I'd caution that believing in this company could become financially catastrophic.
who u kidding ur basing in off of my rants / raves, and solutions,, u have been a follower since u have been here,,polease-sir,, take a step back,, let the real opionions come foeward
The prior disastrous financings could have been averted. Right\s or warrants could have been issued to shareholders. Instead, Deerfield and Oxford were allowed to loot the Company.
GTHP has previously raised funds by issuing warrants to shareholders.
Forget this horror show and move over to GTHP.
Oxford gave us the same deal they give a lot of other investors. Their warrant coverage wasn't that high.
Deerfield got a great deal, but they also gave us 20 million dollars when we had nothing and they then went on to support us for a couple of years. There was almost certainly an agreement that they would support us beyond that initial investment, which was very risky for them... Plus, Fanapt is pretty much worthless. No one is going to invest in a company for the $4 million it would have brought in each year. The warrant coverage there was a bit much, but it is what it is.
Braeburn has been nothing but fair to us. The initial deal was GREAT (look at BDSI and how they were unable to even find a partner) and they had every reason to walk away after the CRL. They don't give much of a leash to Titan in terms of disclosure, but that is their right as a private company.
As far as Titan and shareholders, I think your underestimating how hard it is to keep a biotech company, the size of Titan, afloat. had they gotten approval, they would have succeed. They didn't... It wasn't their fault and there is no logical argument that would convince me that they didn't get the shaft from the FDA.
Sunil screwed up the original trial by not doing dosing studies.
Also, the patients that were not stabilized were given Probuphine plus Suboxone as needed.
Doesn't that taint the results in the Probuphine arm?
Recruiting could be a problem now. If patients are stabilized on Suboxone, why would they volunteer for the Probuphine trial?
Braeburn is aware of all the problems now. Don't be surprised if they pull out and cut their losses.
They might be trying to find a way to extricate themselves from this mess with the smallest possible hit.
How long does it take to publish meeting notes? How long does it take to read and respond to a proposal? In my world 2 days tops for the former, depending on the size of the job, two weeks on the outside for the latter. We are dealing with a public entity, so money and time are of no consequence. And I'm afraid you were right on the "unreasonable people tend to remain unreasonable". Wish I'd been on that last conference call and asked "What precluded you from simply appealing the FDA's decision?" Feel like I bought shares in a Fellini movie.
It could be any number of things, but I'm leaning towards it being the FDA being difficult.
The requirement that we treat stable patients is ridiculous and really isn't fair to Titan or the potential patients. There is a reason addiction trials, that are run to obtain approval, have always used a patient group that hasn't been on treatment for at least 90 days (most never).
Why would a drug addict who is stable on one med switch to another that isn't approved?