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If no PR by next Friday, we’ll have gone a month without a PR. Anyone know the longest we’ve gone without a PR? I’m thinking this might be new territory.
Don’t forget sixpence.
Good lord, CROs are expensive.
Yes, accelerated approval is what I meant. Thanks for correction. With this approval, it would allow IPIX to skip straight to market, bypassing Phase 3 for now.
I cant remember if IPIX ever mentioned Accelerated Approval in one of their PRs. I thought they did.
Someone correct me if I'm wrong. With today's PR, I really think IPIX is close to selling their product (B-OM) before official FDA approval. If they get Fast Track Designation from FDA, they'll be able to legally sell their drug before going through with a Phase 3 trial.
Looks like a night and day difference in complexity. Thanks Plenty.
Because both trials were the same size. It’s not like one of the trials was ten times the size of the other.
A life spiral?
I don't understand why an 8-K form was used for this? Was this not a PR available to everyone?
It feels like the calm before the storm. I mean this in good way.
This has got to be a record low volume from past few years or longer?
I don’t recall ever seeing such low volume.
That would be glorious.
Pfizer vs. Novartis
From my understanding AA would allow it to the market, while the company continues clinical trials until it proves clinical benefit. This would allow IPIX to leapfrog a Phase 3 trial and get this immediately out to those who need without official FDA approval. Official FDA approval would come if clinical benefit is found from the further clinical trials.
This is the first I've heard anyone mention this as a possibility. It sounds wonderful as IPIX could do further trials, while at the same time selling it legally to those in need.
This is his day job.
If this pace continues, we'll be close to one million in volume for the day.
Very good call.
Big Money
Uhh...6-12 per share would be phenomenal.
Good call!
Good trial results will be amazing news, but may not move the needle very much. I'm afraid partnership news is the only needle mover. The Mako effect lingers.
He's showing the total accumulated progression over the years.
We basically just need demand and volume. These upcoming catalysts should be the ticket if positive. I've never seen such large game changing catalysts since following this stock for almost five years.
Understood. Thanks.
I've felt the same way, but then I thought about new investors coming to this board. We all know it's FUD and can easily ignore it. On the other hand, the FUD may scare off new investors. I appreciate those (Sox, Kahuna, Karin, etc) who fight against these ulterior motives, with cold hard facts, day in and day out.
Novartis
Prurisol puts the "early" in "clearly."
Looking good
Awesome. Thanks for sharing.
It's time to head for high ground.
No volume to counter the manipulation.
Does anyone think the B P2 PoC UP trial not being in the US will hurt its credibility when top line results are released? For example, this trial is not on ClinicalTrials.org, does that make it less official and somehow negatively affect its credibility? Not trying to bash, just curious and looking for reassurance.
You're so wise.
Between 8 - 10
The last I checked, there was more than one Big Pharma.
I don't think that means what you think it means.
Their salaries are nothing compared to the fortunes they'll make when this stock finally takes off into the stratosphere.
This is where I think the trial is taking place.
Just did a quick search and found the last Friday PR was on September 16, 2016:
September 16, 2016
Cellceutix Announces Appointment of Vice President for Regulatory Affairs
Corporate
BEVERLY, MA--(Marketwired - September 16, 2016) - Cellceutix Corporation, (CTIX)("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, is pleased to announce today the appointment of LaVonne Lang, DrPH, to the role of Vice President, Regulatory Affairs.
Dr. Lang has over twenty-five years of experience in a variety of specialty roles with a focus in several different therapeutic areas in pharmaceutical development. Dr. Lang received a BSN, a MPH (Environmental and Industrial Health: sub-specialty in Toxicology), and a DrPH (Health Management and Policy) from The University of Michigan. She served as study coordinator at the University of Michigan Hospital, overseeing clinical trial research in Pediatric Endocrinology. Upon joining Warner-Lambert Parke-Davis, her work included study director and writer in Pathology and Experimental Toxicology as well as Clinical Communications. As Director of Regulatory Affairs at Parke-Davis/Pfizer, she was therapeutic area lead in gene therapy and dermatology.
For the last seven years, Dr. Lang has been a consultant, providing FDA liaison support and serving as head of regulatory for companies focusing on a variety of therapeutic areas, including cardiovascular, metabolic, and inflammatory disease.
She joins an expanding senior management team at Cellceutix, further complementing the recent hiring of pharmaceutical executive, Arthur P. Bertolino, MD, PhD, MBA, as President and Chief Medical Officer, and Jane Harness, MS, MP, as VP, Clinical Sciences and Portfolio Management.
"I am excited to join Cellceutix," commented Dr. Lang, "and work with this team of professionals to help advance investigational products toward FDA approval in areas that could have a positive impact on the public's health."
"LaVonne is a fantastic addition to our team," said Dr. Bertolino. "With our lead drug candidates approaching pivotal, later-stage FDA trials, LaVonne's leadership in regulatory affairs will be of paramount importance as we continue to work closely with our research partners and the FDA towards further validating our drug candidates. The professional relationships that she has built over the years at the FDA, coupled with her extensive clinical and regulatory knowledge, should help ensure that lines of communication with the agency remain open and productive."
Leo Ehrlich, Chief Executive Officer of Cellceutix added, "The strengthening of our senior management team by adding proven industry veterans will help us execute more expediently all of our business objectives."
Anyone know the last time we got a PR on a Friday? It's been awhile I think.