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Black Box changes nothing.
Dr Detroit - where did you see that 4000 physicians have signed up? Do you have a link? - thx
Dr. Detroit - You mean "And probuphine is not approved." YET
Truth - within the next few years? I would hope sooner than that.
ASAM is looking forward to injectable and implantable buprenorphine within the next few years, which will also help with the diversion issue.
The Street is run by Cramer and has always had ulterior motives along with Zachs. These two cannot be trusted for anything IMO. GLTA
Thanks exday for keeping us informed today
Exday - How do you mean they cannot defend themselves?
Exday - how is the adcom going this afternoon? Saw you said pre lunch went well and do not see many other comments?
that 6.6 conclusion was from the the last NDA submission not this one- I made the same mistake when seeing this
To Interstate about finding negatives - the doc is filled with negatives - one big example
Section 5.5 This does not look good to me.
5.5 Discussion
The results based on the protocol-specified an alysis demonstrated that the proportion of responders among patients blindly switched
to Probuphine was non-inferior to the proportion of responders who continued on sublingual buprenorphine. However, the
responder rate depends on a number of assumptions about missing data and also assumes that use of supplemental buprenorphine is not an indicator of inadequacy of treatment.
When analyzed under different assumptions, the response rates are lower than reported by the Applicant, and also differ from the e
xpected response rate used to calculate the non-inferiority margin. Therefore, under some sets of assumptions, one might question
whether enough of the effect size has been maintained to conclude efficacy of Probuphine. Moreover, because Probuphine ensures compliance, one would expect a clearer demonstration of superiority over sublingual buprenorphine than was
demonstrated in this trial.
I sold 7/8 of holdings and when I read the following conclusion I think that we got taken again.
6.6 Conclusion
In summary, despite an enrichment strategy which enrolled patients considered responsive to buprenorphine, only a very
small minority of patients treated withProbuphine at the recommended dose seem to have accomplished substantial
improvements in their drug-use behavior, even over six to twelve months of treatment.Taken together, concerns about the clini
cal significance of the primary analysis, pharmacological reasons to doubt the dose would be effective in blocking exogenous
opioids, and the expectation that in the “real world” clinical setting, almost every patient will require ongoing sublingual buprenorphine
to supplement Probuphine treatment, led the review team to the conclusion that the benefits of Probuphine, at the dose tested, did not outweigh the risks for the population studied.
Adcom for TTNP - is it data, insertion/removal procedures, both or something else? I thought no Adcom this time round.
Dr Detroit - I cannot get that to come up even with advanced search - what did you put in the search? - thx
From Titan IR:
It basically just means that warrant holders can (a) exchange their warrants for shares and (b) trade those shares without the company having to go to the expense of filing a registration statement to cover them.
I would like to see Rubin, Sunil and Beebe buy 250k each - they can afford it - 10k here is a token
matt - can you explain the warrants? thx
Link to todays Webcast
http://www.wsw.com/webcast/rrshq25/ttnp/
I saw a tweet that Titan was attending
http://www.prnewswire.com/news-releases/rodman--renshaw-2015-annual-global-investment-conference-to-be-held-in-new-york-from-september-8-to-10-2015-300110562.html
They are on the list above
I sent Titan an email asking if they were attending but doubt I will receive a reply.
Truth - you are right - Everyone should look at DVAX that did 10 to 1 reverse split this past November and has done really well since -
Look at dvax this year - went up after reverse split. Like ttnp was given crl around the same time and completing phase 3 again.
Even still - the fact that it has not gone (or come back down to where it was before the study news) is of concern to me. I was hit by the last CRL and have not yet recovered. Obviously, yesterdays presentation did not impress - this is an OTC stock run by quasi professionals and trading coincides with their history.
Did anyone listen to the cc? I tried but had problems with the mac and media player - ridiculous
Kilmer has been an Apple Tree collaborator IR guy for a while. I agree, good news warrants some epertise -
Ask Jason what he means something is up - you never know with Titan - If it was bad most companies would disclose before the weekend but who knows with Titan and Sunil...
From the Seeking Alpha article by Napodano - Titan's Phase 3 trial with Probuphine is fully-enrolled and we are expecting data in June 2015. Where did you find July or August?
Jason N is hardly ever right and a low level analyst IMO - what will occur has nothing to do with his predictions - look at the past.
No shares traded yet?
My faith in management is very low. Got screwed last CRL and Sunil remidns me of someone from CNBC's American Greed: Scams, Scoundrels and Scandals". Hopefully Braeburn can make this right.
Per twitter user Brian Thomson ?@CatalystWatcher
Victoria writes that Dino expects to make the announcement early next week and to discuss the FDA's findings. Limited vs. full. Seems conf.
Watching and praying but it keeps on going down. Leak, hedging by funds, manipulation ? lots of chatter but no one knows. Watched PATH recently and it went down everyday before PDUFA approval. I think even on limited approval pps will suffer. I blew it because of greed - had lots of shares for a long time and had the opportunity to take profit -
Where id that runup? geesh even with AF's blessing we are down.
sampaloc- That is total BS from Sierra World Equity which is a farse http://biotechnewsstockreview.blogspot.com/2013/01/pfizer-pfe-shows-renewed-interest-in.html
If it gets near 4 before PDUFA I would be very happy.
thanks for the reply - So you see no approval at all or a limited approval for 40 and over with a P IV study request?
OldBerkeley - you really think DVAX will run to 4?
I do not think a pr is coming - below is the response from IR at Arena when asked - Can you tell me whether Arena has sumbitted the 120 day questions ? I understand 10/25/12 was the last day and see nothing in regard to press releases.
We previously stated that we plan to respond to the 120 day questions this quarter. We will provide an update on our upcoming third quarter financial results announcement.
I still cannot believe there has been zero news on this mess. Will take my loss before the end of the year to counter my humble gains . Does anyone think anything will transpire before year end?
I cannot believe there has not been any info for so long. How can that possibly be? Even if ccme is totally fraudulent you would think something would have come out by now. Disgusted to say the least.
I have held on but this is so ridiculous. Zero communucation from CCME - not a word fron anyone. Very hard to imagaine any good can come out of this for the shareholders.