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Thanks so much Karin. I fully understand if it's not possible or if you want to focus on the presentation itself. Safe travels to SF.
Would you be able to shoot a few pictures and maybe a video? Could be great to get a feeling of the place and the people.
Great. I sent this to Dr. Gupta.
@drsanjaygupta You should do a segment about #Brilacidin. It's QIDP about to enter ph3 fast track. The answer to the super bug problem.
— FarmaZutical (@farmazutical) January 8, 2015
April in Copenhagen brings us past 90 days. One of the Worlds most beautiful cities at that time a year btw.
My bad. VP. Not US based. Sorry.
I spoke with a Merck CEO some weeks ago. He had never heard about Brilacidin. But he listened very carefully. Maybe they are catching up now but he had no knowledge of CTIX or B at that point. Maybe others in Merck do but this guy is pretty high up and didn't have a clue.
From Leos special alert:
"Shareholders have alerted me that it seems professional short funds are at it again. For those who are unfamiliar with stock shorting, it is the hope by these shorters to have the share price of Cellceutix stock decline so that they can profit."
Is Leo implying that "funds" and not individuals (Ben Shady) are "at it again." This would mean that the SA hit piece is only part of what to expect this time ?
Maybe. Hope not. Think not. But, yeah. Maybe. Only saying that I like the way Leo handled this one. And that it might save us a month or two in order to uplist. Maybe.
I felt the same way. But with a possible uplist in the (near) future I think it's wise to make an effort to keeping pps above 4. Also, Leo probably wanted to address the questions and concern going on amongst shareholders after the ($)hit piece. Again, he cares. I like that.
Is my mind playing tricks on me or didn't Leo respond to an email recently saying that the bottom line results would be made public "way before" January 12th ?
I was by no means referring to you or anybody here. Merely the ones who read SA and invest according to the advice given there.
I hope that even the bluntest knife in the CTIX drawer will be able to spot the SA authors complete and utterly lack of credibility. How come all the world class dd that's presented on this board has no impact on the share price while a bs hit piece on SA gets a lot of attention ? SA is not the WSJ. It's just platform for average Joe and whomever wants to play stock analyst. The SA brand does NOT give the articles posted there any credibility. I appreciate that folks like Karin an others with real insight also post in SA once in a while but the quality the bring to the place does not spill over. I find it both funny and sad that such a botched up article can gain so much traction.
Article about a pre-clinical "breakthrough" that seems to be an early version of what Kevetrin has already proven to do in PH1.
http://www.sciencedaily.com/releases/2014/12/141230145202.htm
A very interesting article about the race for finding new antibiotics. And, again, a clear sign that CTIX is very well positioned with Brilacidin.
http://cen.acs.org/articles/92/i24/Bacterial-Battle.html
Thanks.
Is that event available as a webcast? If not, could one of you record it with the voice recorder on a smart phone and put it in a Dropbox ?
If you are confused why BP and media don't know about Brilacidin it's because it's way more under the radar than you would expect. I spoke to a top ranking person from one of the Worlds biggest pharmas last week and we discussed CTIX. He didn't know the company and he didn't know Brilacidin. I was a little surprised as one of their main focuses are antibiotics. Just saying that there is still a long way to go before Cellceutix is a house hold name.
Happy holidays, Jest Maybe same time next year we won't be the only ones keeping this place warm. At some point the American investors will wake up.
The EU ratifies EMA approval of SCENESSE. Clinuvel will now begin distributing the implant to key EU member states before expanding to all 28 states + 3. Revenues will soon flow. The educated and smart investor will appreciate that this is an opportunity that comes very rarely.
This is a $10 stock today.
Projected revenues from the EU alone will account for at least $20 million. Add FDA approval in 2015 and that will double. Very low ball: $40 million PACME. Most likely closer to $50 million. App 50 million shares out. $1 EPS X 10 = $10 pps.
Add positive Vitiligo Phase IIB results Q1 2015 and pps should be at least $15.
Label extensions in 2015/2016 and we're at $20. Low ball.
Vitiligo approval in 2018/2019 = (insert very high number of your own choosing)
http://www.clinuvel.com/en/investors/news-publications/announcements/2014-announcements/european-commission-approves-scenesse®;
OK. We'll see. Again, doesn't really matter if it's one or three months does it. Only contributes to HBP constantly chasing the next pr. CTIX will get there eventually. Might take some years, though. That will be when the momentous word would be appropriate.
I do. But do you really expect data collection, submission, FDA analysis and the actual meeting to take place in January ? Anyway, doesn't matter. Delays are often counted in years. This is obviously only a matter of months.
You might be right. But this is the FDA. Federal Delay Agency.
Yeah. The FDA can grant various types of meetings. If a face to face meeting is not possible or if that would take too long to establish they usually offer a phone meeting or a video conference. Actual face to face meetings are held in MD. End of phase II / pre phase III meetings are so called Type B meetings and should be scheduled to occur within 60 days.
I don't think Leo and co. actually visited the FDA last week. I think they were granted a tele conference where the FDA asked for the additional PK data. The actual meeting will most likely take place Q1 2015. Feb / March at the earliest. Nothing alarming in that. Just a standard delay. Be prepared for many more to come. I am.
Overall a very positive pr filled with encouraging info. CTIX is doing very well indeed.
If Leo hadn't used the momentous word which made everyone jump up and down today's pr would stand out as a very positive announcement. Now it's the conveyor of a delay and broken promises.
Biopharma means delay. And once you think the show is on the road be prepared for yet another delay. If thinks run smoothly, be happy. If there is a bump on the road, be patient.
I have the deepest respect for Leo and especially Dr. Menon. And I like the fact that Leo respects us shareholders too. So much that he spends lots of time communicating with us to a degree that is unheard of in other companies. But the momentous pr should serve as a lesson not to expect dreams come true in a month.
Today's pr is great. Just not as great at some were hoping. The CTIX dream will come true. Just not this month.
Next stop, January 12th. All aboard.
Sounds very reasonable. I too think 2017 will be the year when Brilacidin hits the shelves. Compared to other biotechs 2-3 years waiting time is nothing.
How many P3s do you think we will need ? Could one be enough ?
PDUFA target date = possible FDA approval for Brilacidin.
Interesting background on QIDP. First 3-4 pages.
http://c.ymcdn.com/sites/www.iacprx.org/resource/resmgr/FDA/QFR_Response_Woodcock__Healt.pdf
OK. So would you say that PDUFA for Brilacidin is within reach in 2016 then ? That would be remarkable. And great.
What are the expectations concerning the timeline for bringing Brilacidin to market ? If we look at Cubist and the just approved Zerbaxa which btw also got QIDP designation and priority review they published topline results late 2011. 2 pivotal phase 3s and 3 years later they got the FDA approval a couple of days ago.
Now, Cellceutix began patient enrollment for Phase IIb in February and we are now awaiting bottom-line results and a Phase III seems imminent. Obviously, Leo moves very fast but will we need one or two Phase 3s ? And how many patients will be required ? The Phase IIb enrolled 215 patients and I think a pivotal P3 will require at least 4 times that.
So isn't a PDUFA date somewhere late 2017 or Q1 2018 a fairly realistic bet for Brilacidin ABSSSI ?
This is why I'm not a fan of big promises. I prefer over-performing.
I'm not sure if this one has been posted before:
The way I see it "momentous" hasn't happened yet. The QIDP designation comes on top of the other catalysts this month and sparked a buying spree nobody really expected. Very nice. But the news we are - and were - waiting for has not materialized yet. So if the spike in share price was only due to the QIDP we should be in for some really heavy buying once the actual news arrives.
Your rich / wealthy comment made me think of this article. I think Leo wants to change the world. Not "just" make money. He seems way to passionate about the CTIX project to only be in it for the money. So does Dr. Menon.
http://elitedaily.com/money/entrepreneurship/difference-rich-wealthy/
Your posts a highly appreciated. Thank you BH.
When P is a billion Dollar product I will buy a bar and let you choose the drinks for happy hour.
This one could be interesting too:
Cellceutix is preparing a poster on the completed Phase 2b clinical trial for presentation at the 25th European Congress of Clinical Microbiology and Infectious Diseases, which will be held from April 25 – 28, 2015 in Copenhagen, Denmark.
Imagine the magnitude of the disappointment if we only get
minor updates this December. That would be momentous. I'm not a fan of big announcements prior to material news actually materializing.
Too much risk of disappointing the market.
Like saying to the kids: Today you're going to experience the most exciting thing you'll ever live to see. You will wet your pants in joy. They think you're taking them to Disney Land. In fact you're taking them to the local moon bounce.
Fingers crossed that Leo actually delivers momentous news. I'm in heavy.
I'll vote for #1
Trimel signs partnership deal with ENDO to market Natesto.
http://www.stockhouse.com/news/press-releases/2014/11/24/trimel-announces-exclusive-license-agreement-with-endo-for-natesto-tm