Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Ok, I will be watching in the moring. I was there with you in Trius, where I think most of the bitching was from shareholders, with the outside threat as well..
NR, I guess I should not be surprised at a vulture law firm attempting greenmail at CYNA's expense.
http://finance.yahoo.com/news/cynapsus-therapeutics-inc-acquisition-may-195700612.html
Thanks for posting the presentation FUN.
Guitar,
Sometimes they make a holiday package available in retail stores, including both the bottle of Black Seal AND a couple bottles of their ginger beer. At least where I shop, it's the same price for the box as for just a bottle of Black Seal.
Well, at least they concede they need to make it available online.
No, you must have hit one of your speeddial buttons by mistake.
Thank you Karin
I hope they release the presentation as well. Perhaps several of us should email the IR people.
EDIT: I just sent the am email to that effect.
No argument. Everything they do is self-serving, rather than selfless
Glad to be back $oldier, tho not with as much time available.
When a company comes out with a rating on shares in which I am interested, I try to look up their disclosures. Not always easy to find, if even there, but I always suspect pay to play from some of these services.
There is no reason to change ratings that quickly.
Diz, ...and you sleep better for it, right?
Fun, Well, if Trey and the Captain had to "lighten" the boat, I know what they could have consumed.
Imagine two of us noting that! It would be absolutely incredible if someone else observed that too. <grin>
$oldier, just checking in. Regarding your discussion of just how Zacks comes up with their ratings, if ROX were to retain Zacks for investment advisory services, I suspect the rating would immediately shift to Buy or Strong Buy. Just IMHO.
Glad to hear it will be dry there
Au contraire, my friend.
Lola, The two patents were already stayed pending the IPRs (this was well known and not news). This was simply confirmation that the proceedings were being allowed to continue using the third patent.
Yes, always prefer good news myself.
Would you please summarize what the documents said. Anything we can wrap our heads around? TIA
More bee stories:
http://fusion.net/story/343150/south-carolina-zika-bees-dead/?utm_source=fusiondaily&bt_ts=53355&utm_campaign=09012016&bt_app_member_id=8d03a217e6f54a5c0bc8d3d932959615&utm_medium=email
http://www.npr.org/sections/thesalt/2016/08/12/489622982/the-colony-killing-mistake-backyard-beekeepers-are-making?sc=17&f=1001&utm_source=iosnewsapp&utm_medium=Email&utm_campaign=app
I consider most of your posts unhelpful and disingenuous for real investors.
However, in this case, you were asking a reasonable question that I would expect of someone without an extensive background in investing. The question could have been asked by many newbies, so I tried to give a reasonable answer.
I gave you the benefit of the doubt in this case and do not think you are 100 percent beyond redemption.
Scotty, It's the arbitrage discount. Even with a definitive agreement signed, it is always possible a deal can fall thru or that yet another party (perhaps another suitor which was rejected) can sue to block the deal. Whoever is the holder still has a risk. The greater the risk that the deal may not go thru, the greater the discount.
Please share the ideas!
Yes, I agree. An island on which to wait for our other ships to come in.
Seel, But now you can have servants to carry your palanquin. (and I'm going to make everyone look that up)
Thanks to you and Noretreat for leading me here.
While I might ordinarily consider just selling on the open market in the morning, my question is what is the likelihood of an offer by another pharma to top the $40.50/share price?
Karin,
In the case of Cellceutix's drugs, I believe we should have a better than average chance of advancing to the next Phase in each compound because of how sharp Menon is in interpreting the data and deciding what compounds should advance at what dosages. All IMHO, of course.
From report: Clinical Development Success Rates 2006-2015
"Executive Summary This is the largest study of clinical drug development success rates to date. Over the last decade, 2006-2015, a total of 9,985 clinical and regulatory phase transitions were recorded and analyzed from 7,455 development programs, across 1,103 companies in the Biomedtracker database. Phase transitions occur when a drug candidate advances into the next phase of development or is suspended by the sponsor. By calculating the number of programs progressing to the next phase vs. the total number progressing and suspended, we assessed the success rate at each of the four phases of development: Phase I, II, III, and regulatory filing. Having phase-by-phase data in hand, we then compared groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis yet of biopharmaceutical R&D success.
This work was made possible due to the years of clinical program monitoring and data entry by Informa’s Biomedtracker service. BIO has long partnered with Biomedtracker to calculate success rates based on this data. More recently, BIO and Biomedtracker partnered with Amplion, the inventors of BiomarkerBase, to analyze the effects of biomarkers in clinical trial success.
Key takeaways:
• The overall likelihood of approval (LOA) from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology.
• Rare disease programs and programs that utilized selection biomarkers had higher success rates at each phase of development vs. the overall dataset.
• Chronic diseases with high populations had lower LOA from Phase I vs. the overall dataset. • Of the 14 major disease areas, Hematology had the highest LOA from Phase I (26.1%) and Oncology had the lowest (5.1%).
• Sub-indication analysis within Oncology revealed hematological cancers had 2x higher LOA from Phase I than solid tumors.
• Oncology drugs had a 2x higher rate of first cycle approval than Psychiatric drugs, which had the lowest percent of first-cycle review approvals. Oncology drugs were also approved the fastest of all 14 disease areas.
• Phase II clinical programs continue to experience the lowest success rate of the four development phases, with only 30.7% of developmental candidates advancing to Phase III."
Later:
"Phase Transition Success and Likelihood of Approval (LOA) - Overall Consistent with previous studies of drug development phase transition success rates, we found Phase II success rates to be far lower than any other phase.1 Phase I and III rates were substantially higher than Phase II, with Phase I slightly higher than Phase III. The highest success rate of the four development phases was the NDA/BLA filing phase.
The Phase I transition success rate was 63.2% (n=3,582). As this Phase is typically conducted for safety testing and is not dependent on efficacy results for candidates to advance, it is common for this phase to have the highest success rate among the clinical phases across most categories analyzed in this report. Phase I success rates may also benefit from delayed reporting bias, as some larger companies may not deem failed Phase I programs as material and thereby not report them in the public domain. The Phase II transition success rate (30.7%, n=3,862) was substantially lower than Phase I, and the lowest of the four phases studied. As this is generally the first stage where proof-of-concept is deliberately tested in human subjects, Phase II consistently had the lowest success rate of all phases. This is also the point in development where industry must decide whether to pursue the large, expensive Phase III studies and may decide to terminate development for multiple reasons including commercial viability. The second-lowest phase transition success rate was found in Phase III (58.1%, n=1,491). This is significant as most company-sponsored Phase III trials are the longest and most expensive trials to conduct.
The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking into account re-submissions, was 85.3% (n=1,050). Multiplying these individual phase components to obtain the compound probability of progressing from Phase I to U.S. FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market (Figure 1).
63.2% Phase I to Phase II
30.7% Phase II to Phase III
58.1% Phase III to NDA/BLA
85.3% NDA/BLA to Approval
9.6% Phase I to Approval
...(did some reformatting here as numbers were in a table)
Probablity of Success
All Diseases, All Modalities
Figure 1. Phase transition success rates and LOA from Phase I for all diseases, all modalities.
BIO Industry Analysis"
NanoAntibiotics Changes Name to BioVie and Welcomes Dr. Patrick Yeramian to Clinical Team
BY Market Wire
— 8:00 AM ET 08/22/2016
BEVERLY, MA -- (Marketwired) -- 08/22/16 -- BioVie Inc. ( BIVI) (the "Company," formerly NanoAntibiotics, Inc.), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today that shareholders have approved changing the company name to BioVie Inc. ( BIVI) The Company's stock will now trade under the symbol "BIVI." More information is available at www.biovieinc.com.
BioVie ( BIVI) also welcomed Dr. Patrick Yeramian as consultant Medical Director to guide the clinical development program for the Company's new drug candidate, BIV201. This novel therapeutic is based on proprietary CIPT Technology and is being developed to treat ascites due to liver cirrhosis, a life-threatening condition. "Dr. Yeramian's broad experience, proven track record, and professional connections make him a great addition to our team. He has already made important contributions to our investigational new drug (IND) application which is progressing ahead of schedule. His expertise will be invaluable for clinical trial execution," commented CEO Jonathan Adams.
Prior to joining the BioVie ( BIVI) team, Dr. Yeramian worked with the Company's regulatory expert, Stacy Suberg, Ph.D. "I've worked with Stacy on successful clinical trials in the past. I look forward to working with her again, and the other members of the BioVie ( BIVI) team. The therapeutic concept behind BIV201 is based on compelling data, which spurred my interest in the clinical program," commented Dr. Yeramian.
Dr. Yeramian brings three decades of experience in research and drug and medical device development to BioVie's ( BIVI ) management team. He has served as a medical director for multiple organizations including Searle Pharmaceuticals (now Pfizer), the Vaccine and Gene Therapy Institute of Florida, and TapImmune Inc. During his career, he has helped companies secure over $25 million in grants and awards, filed more than 20 investigational new drug and device applications (INDs/CTX/CTAs), and won regulatory approvals for five new drugs and devices.
BioVie's ( BIVI) immediate goal for BIV201 is to commence a clinical trial as early as 2017, contingent on FDA acceptance of an Investigational New Drug ("IND") application, which is currently in development. For more information, please visit our website www.biovieinc.com.
About Liver Cirrhosis and Ascites
About one million Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients may fail to respond to treatment as ascites worsens. This unfavorable prognosis represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About BioVie ( BIVI) (formerly NanoAntibiotics)
BioVie Inc. ( BIVI) is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug ("pre-IND") meeting with the FDA, which provided guidance for an IND submission. The Company's new drug candidate could potentially commence US clinical trials as early as 2017.
All buckled in.
deleted
Your analogy works for me. I would not want to be Drose.
Grease, Perhaps this operation did not go as well for the wolfpack, but they did make some serious coin by shorting, if they sold near the bottom. They also attacked other public companies, including Cellceutix, with major profit to them and cost to longs.
EDIT:
What was the old TV program or movie where "mother" was the leader of the evildoers?
"Fed to the wolves" is a reference to the old Russian story of a mother and her many children on a long trip crossing the snow in their sleigh. A pack of wolves is chasing them and is gaining on the sleigh. If the mother throws one child overboard (to the wolves) the wolves will stop and the sleigh will be that much lighter, so the rest of the family can escape.
Under this framework, Drose would be fed to the wolves by the rest of his cohorts to save themselves.
I'm sure Dr. Frost would not be too disappointed if CDXC sold for a nice premium to DSM.
Yes, TigerX was the one.
I agree that Opko is his primary "baby" of which he is very protective. However, he has quite significant stakes in several others (like CDXC) which I would guess that he may ultimately wish to acquire control of and roll up into the Opko shell. After all, that's how he did it with Ivax and with Key Pharma. I did hold at least one company he has already merged into Opko.
Holdings like Pershing are perpheral and would not fit within the next pharma giant and so were expendable.
I guess he felt comfortable enough selling some CDXC to support the others. We'll see if he builds his stake back up thru exercise of options.
When Frost sold his Pershing shares, he invested virtually the same amount in another stock that or the next day, but it was not OPKO. If you look at his insider transactions, it will become apparent.
Similar patterns might be visible following the sale of the CDXC shares. I'm too tired and perhaps too lazy to look tonight.
Well, Drose certified in his disclaimer at the end of the article that he had written the article himself. SA COULD do something, like perhaps banning him, but I don't consider that likely.
You can always send a PM yourself on Fridays between 4 and 5 pm ET (happy hour) or ask that someone with PM privileges give you an email addy at which you may contact them.
You have been making many excellent posts and I hope you continue. I'm a long-time holder of CDXC, but just a free member myself.
Yes, either Drose and his attorney just dug a fairly deep hole or someone is going to feed Drose to the wolves. It will be interesting if they keep digging the hole deeper or if Drose squeals on his erstwhile "friends."