I expected the pps to rise sharply after the CC. I always forget that Sunil is in charge and he never puts out a positive spin on anything. Has the pps ever risen after a Sunil PR?
I hoped that Titan would have gone on the offensive and had already scheduled an FDA meeting and assured shareholders they will try to have the issues resolved without new trials and are prepared to file an appeal and pursue dispute resolution if necessary.
Sunil said nothing to give me cheer and the market reaction was a yawn.
The silence of Braeburn and the PR machine that they hired gives me pause too.
I have little confidence in management doing the right thing for shareholders.
I'm now fully expecting Braeburn to make a pathetic buyout offer of .75 and Titan management endorsing it as a fair deal.
My 5 year old niece can do a better job running the Company.
Silly poster, I own more shares than Bozo Bhonsle.
I'm as happy as you are that the stock hasn't gone anywhere but down for years.
creppie said that we should be happy with $1 (a double from today's depressed price).
If the pps drops to .10, we should then be happy if it doubles to .20?
$1 is pathetic. When Rubin came on board, the pps was $2.40. If our management idiots can't increase shareholder value ( instead of demolishing it), they should do the honorable thing and resign.
So, Braeburn determined in good faith that additional lengthy trials will be needed before they even hold a meeting with the FDA? I'm sure that Titan would be agreeable to extend the 30 day period until clarification is received to enable a good faith decision to be made.
If it's already clear that extended trials will be needed, then why hasn't that been disclosed by Titan?
Braeburn could have intentionally given the FDA a difficult time during the REMS discussions to precipitate a CRL. Perhaps the topics of dosing and the hesitancy by some practioners to perform the implant procedure dissuaded them and they intentionally sabotaged the NDA to save the $50 million due on approval. Or......they were shrewd enough to plan a take over of Titan. I don't trust Rubin and his buddy at Braeburn.
NDA Transfer Date will occur on or after January 1, 2015 or (y) that the costs of such Additional Registration Studies would exceed ***, then within thirty (30) days after receipt of such complete response letter, Braeburn shall, in its sole discretion, have the right and shall notify Titan in writing of its decision either to (xx) terminate this Agreement upon thirty (30) days written notice to Titan, or (yy) continue to proceed to obtain FDA Approval despite the foregoing, in which case, Braeburn shall have the right to set-off against the required milestone payment set forth in Section 6.1(b)(i) an amount equal to the amount by which the actual costs of the Additional Registration Studies exceeds *** up to a maximum set-off of *** (the “ Milestone Set-off ”)...........................
" in the event (A) Titan receives from the FDA a complete response letter advising that the Product NDA as filed by Titan for the Initial Indication will not be approved and that additional clinical studies and/or other development will be required to be performed prior to receipt of Regulatory Approval of Product for the Initial Indication (“ Additional Registration Studies ”) and (B) such Additional Registration Studies would materially adversely impact the timing or cost required to be incurred by Braeburn for such Regulatory Approval such that Braeburn reasonably believes in good faith either (x) that that the........
I don't have the exact letter. I submitted it on the Senator's website.
It would have been something like this:
"The drug addiction treatment market is controlled by a monopoly by a foreign company, Reckitt Benckiser.
Titan Pharmaceutical, an American company has an innovative product to treat this epidemic of illicit drugs and pain meds.
The FDA's own AdCom panel of experts overwhelmingly endorsed Probuphine to be safe and effective.
On Tuesday the FDA shockingly went against the panel and denied approval.
It raises questions of undue influence by the giant Reckitt Benckiser to retain it's profitable monopoly.
Titan Pharmaceuticals developed an innovative abuse proof implant to combat the diversion of illicit drugs.
It' a tiny rod shaped implant which releases buprenoprhine for a six month period.
The addict would not need to continue popping Reckitt Benckiser's Suboxone and enforce an addictive behavior.
Buprenorphine is an already safe and effective drug. The minor procedure to implant the rod under the skin is also safe and effective.
The FDA's recent mission statement is to promote abuse proof medications.
This decision to deny approval of a safe and effective abuse proof treatment reeks of corruption."
I thought that Braeburn could terminate the agreement only if in good faith they determine that Probuphine could not get approved before 2016. They can't possibly make that determination until they have a meeting with the FDA and the FDA would have to insist on lengthy new trials.
How did you come up with the "13 more days"?
Dear Mr. xxxxxxxxx,
Thank you for contacting me to express your thoughts on the FDA. Your opinion is very important to me, and I appreciate the opportunity to respond to you on this important matter.
I have forwarded your letter to the Food and Drug Administration (FDA), who can better address your concerns. Please know that should I receive a response from them, I will forward it directly to you.
As your United States Senator, I rely on the important communications I receive from my constituents to guide my work in Washington. Please be assured that I will keep your views in mind should legislation addressing this issue come before the U.S. Senate.
Again, thank you for sharing your thoughts with me. Please do not hesitate to contact me if I can be of further assistance.
It's discounted. $430M discounted to $300M.
That's using minimal annual sales. Projected peak sales are $300M+.
The above computation also gives no value for Probuphine for pain and for ProNeura for Parkinson's.
Everything points to $3 per share buyout.
What's TTNP's value to Braeburn?
If Probuphine has a good chance of getting approved:
Titan has $15M cash in the bank from Braeburn
Braeburn will pay out $50M on approval
Braeburn is on the hook for $165M in milestones
Braeburn has to pay out a 20% royalty (even if sales are only $100M per year for 10 years, that's $200M)
Braeburn gets ProNeura for free.
$3 per share would be a great deal for Braeburn.
On a buyout, Braeburn gets back the upfront payment of $16M, plus they save the $50M on approval, plus the $200M in milestones, plus the double digit royalty and they also pick up ProNeura for Parkinson's.
How much is all that worth?
Mr. Brown, an expert in artificial intelligence, is vice president and director at Renaissance Technologies. The fund company said recently its total assets were about $18 billion. Mr. Simons was the top-paid hedge-fund manager in 2008, receiving $2.5 billion, according to Alpha magazine.
A lengthy review by the Government Ethics Office, which included direct discussions with Renaissance managers, determined that both Dr. Hamburg and her husband will have to get rid of their interest in four Renaissance funds—the Renaissance Institutional Equities Fund, the Renaissance Institutional Futures Fund, Meritage Investors and Topspin Partners.
However, the couple will be allowed to retain their interest in Renaissance's Medallion fund. An administration official said Medallion was exempted because its computerized quantitative model trades rapidly and holds shares only briefly, creating the equivalent of "a very blind trust."
Its programming does not allow for human tracking or input except in rare instances, meaning that neither Dr. Hamburg nor her husband would be in a position to direct their Medallion account to companies or areas affected by the FDA.
The Medallion Fund paid Dr. Hamburg between $1 million and $5 million last year, and more than $4 million to trusts held by her and her family.
Renaissance is currently the subject of some investor complaints because RIEF, held mostly by outside investors, has been losing money, while the Medallion fund, held nearly exclusively by Mr. Simons and his colleagues, racked up big gains. Renaissance managers say RIEF never was advertised to provide the same returns as Medallion, which they say has a different investing strategy.
Mr. Brown has already sold his stock in Abbott Laboratories ABT -0.30% and shares in Johnson & Johnson, JNJ +0.81% Merck MRK +0.25% & Co. and Medco Health Solutions Inc., which he inherited from his father. The couple will be allowed to keep their part ownership in the Brown family's Rockland Farm in Middleburg, Va. Because veterinary medicines and animal health issues are covered by the FDA, they have removed themselves from all management decisions.
WASHINGTON -- The new commissioner of the Food and Drug Administration is among the wealthiest Obama administration appointees, with income of at least $10 million in 2008 thanks mostly to her husband, a hedge-fund executive, according to financial disclosure forms.
Margaret Hamburg and her husband, Peter Fitzhugh Brown, must divest themselves of several hedge-fund holdings as well as some of Mr. Brown's inherited drug-company stocks so Dr. Hamburg can take the post as the nation's top food and drug regulator. Mr. Brown is a lieutenant to hedge-fund magnate James Simons.
She was confirmed by the Senate last week. The couple's income in 2008 came from stocks, money-market accounts, trusts and funds including several affiliated with hedge-fund sponsor Renaissance Technologies, where Mr. Brown works.
The couple controls assets worth between $21 million and $40 million, according to disclosure forms Dr. Hamburg gave the White House. The forms don't reveal exact figures, just ranges.
Dr. Hamburg will make about $150,000 a year at the FDA. She is a former New York City health commissioner and served in the Clinton administration. More recently she has been affiliated with several nonprofits including the think tank Nuclear Threat Initiative, which paid her $100 a year as its senior scientist.
Before her FDA nomination, Dr. Hamburg also served for five years on the board of Henry Schein Inc., a $4 billion firm that distributes medical and dental supplies including vaccines. Her remuneration has been in the form of Schein shares.
She will forfeit $100,000 to $250,000 in restricted stock and more than 11,000 unvested stock options, all of which have a strike price above market value. She will also have to sell vested stock, valued between $250,000 and $500,000.
Sunil, hold a CC and let shareholders know what is going on. What are the options on the table?
If Probuphine were approved you would have had a CC to cackle and bask in congratulatory analyst fawns.
It is more important to hold a CC after the FDA denial and inform shareholders about the avenues available to the company, the time frames, the financial situation, the Braeburn relationship now, the Huckel resignation, thoughts on downsizing, sale of the company..........
Sunil tends to disappear at a time when shareholders need answers and when leadership is needed,.
Based on the chart:
First up leg: .65 to $1.12 ..... about a double
Second up leg: .75 to $2.50 .... about a triple
Third up leg: $1.00 to ??? ...... I'm looking for a quadruple to $4
The PDUFA catalyst date is known, yet stocks still generally soar on approval.
Don't discount tomorrow. The FDA will release its comments on the NDA tomorrow.
ARNA was up some .60 on that catalyst.
TTNP could be up 20% to 30% tomorrow, to a new high, if the FDA notes are positive.
The volume has been high the past few days, with the vast bulk of it on the buy side, but there is an impenetrable wall at $1.95. There's no indication that people are holding off putting money into the stock. The volume would drop off if that were the case.