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BigKahuna, if Krishna Menon finds a way to convert the current B-ABSSSI IV into a 1 or 2 day oral pill in 2015 or 2016, would this be granted automatic Phase 3 trial and would it be granted those same speedups from the FDA that CTIX is currently looking at for Phase 3?
Agreed, they had to have known about B.
Maybe they are one of the big pharmas in talks for Brilacidin, but had one of the lower offers and went on there way to Cubist and offered.
Maybe they have a deal for Cubist and a later revealed partnership deal for B (all indications). This way they can replace Dapto with B in 2 years and they get the revenue possibilities of the other B indications. Kind of like a merger plus a partnership to build up the anti-infection drug suite they are getting from Cubist.
This is only speculation.***
Nice post it is upside down for sure - we won't be walking on our hands in the future. Science and data will trump down the road.
When your job income doesn't move up much over the years as it used to and groceries move up considerably over a five year span, it sure feels like inflation. And how about those food tricks by the companies with 16 oz packages down to 14-14 1/2 oz or the smaller ice cream cartons and the price still increases. Talipia is the only fish I can find cheap anymore and that won't last in 4-5 years.
Or greener than the Incredible Hulk.
Nicely said. Finish what you started to the point of effectiveness and emotional satisfaction of giving is complete and can be turned over after appreciation of the outcome.
Yes, waiting for the signing of 1-2 big pharma players during the offseason. And there are potentially 5-6 valuable positions that player B may take up on the field.
Yes and we may be in the 1st or 2nd inning of a 7th inning buyout game. I would be happy with even a 20x investment AND KEVETRIN being used as standalone or combo to add many months of months of extra time to patients lives living with loved ones and the hopes of some cures too. AMEN.
Late 2013 summary reading of Cellceutix compounds for this:
http://cellceutix.com/cellceutix-identifies-drug-candidates-for-gram-negative-and-candida-fungal-infections/#sthash.grfwXb7d.dpbs
Quite welcome - a thanksgiving for the bio experiences, facts, statistics and business insights you share about the industry and ctix. Happy Thanksgiving to you, your family, and special friends.
Your welcome, I just stumbled upon it today. Happy Thanksgiving and a restful weekend.
BigKahuna, here is a biotech article discusses biotech collaberations between big pharma and small biotechs...like a partnership,etc...
https://www.fenwick.com/FenwickDocuments/Biotech_Pharma.pdf
Friend, you act as if you knew everything since cohort 2. I'm glad you believe in God, but sometimes your arrogance gets the best of you. This phase 1 was intended to test for safety and hopefully determine some kind of efficiency, but only for now as a once a week dose for patients who have drug resistance to everything else and at stage 4 who are barely given the next day to live. Its wonderful of Cellceutix to offer this option at such a dire time for people looking for hope like the one patient who suffered a DLT at 350 but so desperately wanted to continue and will at 215. Phase 2 will look at multi-dosing per week and a mix of different cancer stage patients to see what situations the highest P21 efficieny can be achieved. Until then, perhaps you should stay somewhat guarded and keep your mouth shut to 100% head nodding of your opinion. Need I say more friend??
Thanks Karin, and 2015 will be quite more busy than 2014 for trial results and data, oops as well 2016. If things fall in line pretty good and by the end of 2018, we earn ($2 per share * 30 pe = $60/share or $3 per share * 20 pe = $60/share), I'll be a very pleased long timer investor.
I think $3 per share at 20 pe is doable sometime in 2018 with all the trials and potential in the pipeline IMO.
Thanks Karin for sharing Leo's reply. Agreed, here for the trials and results from the science which could have gamechanging impact or unmet needs. IMO, I took Leo's comments about shelf filing as for possible use in a partnership deal whose transaction would cause a favorable outcome to the stock price outweighing the short actions on the stock price -- the shorts would be suprised.
Yes, your right BOD is taking time. I think it was mentioned on this board that Phase 3 B trial would probably not start until late spring or early summer. With only 1 1/2 months left in 2014 and lots of news events occuring in 2015, just maybe they are waiting until early spring to finalize the BOD as they think the stock price will rise nicely into Spring 2015 with all the future news catalysts to help them put together a favorable board at a favorable price. You know closer to beginning of Phase 3 B. IMHO
My WAG is this will happen when we uplist to a major exchange and the K phase 1 results are known to the public. Then they can talk up both possibilities B and K and be comfortable with referencing a company on a major exchange.
Thanks Big Kahuna. You did well with as best you can without the data. Look forward to K P1 results and the protocol for P2/3.
Hopefully, they will move to 450 from 315 having the 6 people now.
Maybe that DLT at 315 is preventive in some way and they have figured it out and confident of escalation.
Big Kahuna,
These two K trials would be possibilities for Phase 2/3
1) K against advanced pancreatic cancer-no effective drug or therapy-critical unmet need.
2) K against Retinoblastoma-no effective treatment against advanced stages and especially bilateral cases-critical unmet need. (surgically removing eyeballs from children is abhorrent to our species).
My question is:
3) Would a third K trial as phase 2 include all tumor types that had preclinical success in the lab, stage 2 and stage 3 patients, and multi-doses per week (unlike current phase 1 of 1 dose per week)?
I remember your preclinical graphs for a certain lung cancer with xenograft tissue and wondering if this tumor type would be included in the above paragraph trial #3 or is this for a K combination trial?
Thanks Big Kahuna
2015 is going to be a real business like year with several advanced trials ongoing. CTIX is moving an advanced pipeline forward and I look forward to 2015 and 2016 as good returns on my investment in promising assets (drug platforms) of multiple indications with good possibilities for future standard of care.
The primary outcome of phase 1 is safety, now with very high dosing in play and no SAEs which to me means still nontoxic and no deaths. Quite an achievement at 35x original dose. They know what the data is and will use it as best they can to achieve a successful K phase 2 for whatever tumors in whatever stages it may successfully apply. Of course there is risk in any drug in phase 2. I'll take my chances here with other things in the pipeline and the possibility of K being used as a standalone for stage 4 ovarian and pancreatic cancer patients (not reacting to anything else) who want to live extra time to see a son/daughter's graduation/wedding/etc....If you were translating a 20% kill rate in phase 1 to something even as 1/4 (5%) as such in phase 2 uggghh I hope not. 50 deaths of 1000 patients -- I hope never to see that happen with any drug.
At this high of a dose level above efficacy range, it would seem a good bet that safety was achieved and nowhere near 20% killing of patients. THE IRB knows this isn't a problem, hence we keep moving forward.
Your assuming royalties for all 3 B-indications? The feel of this board made me think it was a partnership based on royalty for just B-ABSSSI. Guess we'll have to wait and see what terms Leo comes up with for a partnership deal.
Big Kahuna, what % royalty did you use to get your B-ABSSSI revenue of 675 million? Thanks.
Big Kahuna, Is it correct in thinking a partnership may take 2+ months as we wait the final report and leverage for best deal from what could be a number of competitive higher offers? One would think the stock price moves up over the next 2-3 weeks based on anticipation of a partnership. Have you seen any license in past having a 30-35% royalty in exchange for 200 million less cash or is the max proper 25% for antibiotics? Thanks so much for all your doing to educate us in the development cycles of drugs and the financial outcomes and possibilities. Have a great weekend there.
1) 1 dose B results equiv D : $5.75 1/1/2015
2) #1 plus uplist : $8 1/1/2015
3) #1 plus #2 plus Big Pharma partner : $15 1/1/2015
this doesn't include any other good news
BioHedge, I'm in this even if we get some and not all good results from everything Kevetrin and the B platforms have to offer. You favor a partnership for B-ABSSSI?? And Kevetrin also?
That would be great! Looking forward to 2015/2016 - if B one dose and BOM success, CTIX will have strong legs under it at eoy 2015 and guaranteed good cash flow sometime in 2016. Plus a partner helps make for a super balance sheet of low debt and cash heavy as if we are already running a good business.
There is excitement because this company bought Polymedix assets (contains Brilacidin platform) for only 5 million. With possible approval of unmet need B drug indications having a significant effect on patient standard of care and the companies financial ability to expand the B pipeline from this.
Big Kahuna: Does this mean that diabetic foot ulcer would only need a Phase 3 trial upon B-ABSSSI approval?? I copied this below off CTIX slides.
ABSSSI as a Development Strategy
Generating Antibiotics Incentives Now
--
GAIN ACT
•
Fast Track Status
•
Priority Review
•
Exclusivity
Gateway Concept
•
Well defined development path with regulatory clarity and many patients
•
Gateway to serious infections with unmet medical need
(i.e. Diabetic Foot Infections,
Infective Endocarditis, Prosthetic Joint Infections, etc..)
•
Once complete ABSSSI Phase 3 trials
?
only need small single Phase 3 trial for serious
infections with unmet medical
Thanks for this. My real hope is Menon and Ehrlich are able to get airtime on CNBC. They know CTIX from the back of their hand and can put it best in words why they may have game changing compounds. They are better for getting the best value out of a partnership deal than Kramer talking trash and not being an internal member of the CTIX team. Leo and Menon hopefully will never be a guest on his show, they should be guests of biotech industry experts.
I hope Kramer never discusses CTIX until it reaches Investor Business Daily top 100. Kramer is too shallow - doesn't do the serious lengthy research to know what he is talking about.
Dr Jerry, I think it was also mentioned of Brilacidin for surgical antibiotic prophylaxis.
I'm happy about the SP movement since late July/early August (within a short 2 months). Unhappy sellers seem impatient to ride the wave or next surge. Lots of news with this company eoy 2014 and all 2015. I'm holding on for this timeframe - I see a ladder in front of me.
Agreed with much left to show and under the radar - development & trials of compound gamechangers in great need...stretch this out to its full value and follow the sistership route. Then Leo and Menon will discuss offering prices in bidding war fashion.
Yes, there are plenty of trials next year - stay on the trail. This company is undervalued - partnership with Big Pharma will give it the value and recognition it deserves. Being in early will let us profit nicely from a proper business valuation down the road.
Yes, Brilacidin as an effective platform will have many medical applications each with 1/2 billion to multibillion $ possibility. Glad its in the front of the pipeline.
There is a fair number of trials going on with ctix from end of this year thru next year. I like the SP move last three weeks and the way the pipeline is moving - 5 burners lit on the stove (B, BOM, K, P, and Bologna K).