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Thank you for posting this as well, but...please always pay attention to disclaimers, such as they have on the last line:
ejob, thanks for posting that link. It is annoying how beneath the radar BIVI is.
ejob, I had reviewed the filed form 4's and form 3's some months ago and they did not match what were the stated share holdings. I then suggested to the COO that they might want to catch up, which they have been doing. The disparity between transaction and filing dates was simply an oversight.
Perhaps it is a minor point and as a long since the days of the predecessor company NNAB I hope so, but "only one" is definitely not the same as "at least one."
That said, I expect BIVI will prevail on the majority of claims.
I have two interpretations.
1. The was no even de facto standard
2. A real small artisinal distiller/bottler could invest less in the product aging in different barrels under different conditions.
Gov, That's why we are in the stock. Not that I know when, of course.
Would be nice to have some good news soon.
Of interest due to Kentucky Artsan Distillers:
https://twitter.com/i/topics/news/e371757339?cn=ZmxleGlibGVfcmVjc18y&refsrc=email
Small Barrels
Join us April 9 for Bourbon Salon at Oxmoor Farm with Kentucky Artisan Distillers
The proposed changes in regulations include a regulation on barrel size, basically making the 53 gallon barrel a requirement for Bourbon. This was pushed for by the large distilleries and probably the cooperages. Many people say it was a way to force smaller distilleries out of business, and while I have no doubt there are marketing people who would love to see that result, I doubt that is true of the manufacturing side of the business. The big distillers all realize that the worst thing that can happen now is for Bourbon to get a bad reputation because the market flooded with poor tasting Bourbon. They imagine a new drinker purchasing their first bottle from one of these small distilleries and really disliking the taste and being turned off to all Bourbon. In my opinion, this is not a problem since a new drinker of Bourbon is much more likely to purchase a bottle of one of the established brands than pay the higher price that the artisan distillers must charge to make a profit. However, that is the rationale behind the barrel regulation – to ensure quality.
Small barrels can create a good Bourbon but it is much more difficult than most people think it is. I have had some good whiskey from small barrels – Kings County and Delaware Phoenix in New York, Dad’s Hat in Pennsylvania and Yellow Rose in Texas, to name a few. However, I have had many Bourbons from small barrels that were simply over tannic and bitter and hardly drinkable. There are things about small barrels that need to be considered in order to make good Bourbon. The purpose of small barrels is to get an aged product out more quickly because there is a greater exposure of the alcohol to the wood.
First of all don’t treat the barrel the same as you would a 53 gallon barrel. Small barrels have thinner staves and generally don’t get as much toasting of the staves while being created. You need the toasted wood to get vanilla flavors in the whiskey. Ask for a little extra toasting when purchasing a small barrel. The next thing is don’t over char the barrel. You don’t want to burn away the toasted wood with the char. You should not overheat the barrel. Top floors of a warehouse are fine for 53 gallon barrels, but a 10 gallon barrel will be dominated by wood tannins and evaporation at the same level.
Next, realize that the whiskey needs to be different in a small barrel. Small barrels have greater exposure to the wood but it still takes time for chemical reactions to happen. Some of the initial wood compounds need time to break down into pleasant flavors. The barrel entry proof should be lower in small barrels. Sugars dissolve in water better than alcohol so more water dissolves the caramelized sugars in the wood quicker. Finally, monitor the whiskey very closely. Small barrels can change the whiskey in a matter of weeks. Don’t let the whiskey get over-aged and bitter.
Small barrels can make good whiskey but it takes a different process than that used in 53 gallon barrels. In the long run distilleries should be making whiskey in 53 gallon barrels for long term growth, but small barrels can be an option for short term needs.
There have been a fair number of insider purchases which are now getting reported. See tranactions reported above.
Chaka,
Ahhh. 88-89 percent gain on the day. Would love to have many more days like this!
Ultimate, Good to see you back.
Didn't I also see some news toward completion of their current study? Can't find it now.
Several form 4s. What appears to be substantial open market purchases by management. Great to see.
The guys who bought control last year have the cash.
Not sure how the studies are progressing on BIV201, but their last 8k (see above) stated that they had reacquired certain rights for terlipressin.
Big percentage changes in the SP but just back and forth. Not much net change.
Deal with Merck for collaboration; upfront amount unstated.
No changes?
Any new intelligence not already filed with the SEC?
According to what I understand from BioVie:
Mallinckrodt is targeting hospitalized patients with Type 1 HRS (meaning the onset of renal and multi-organ failure) with an expected 2 to 4 week median survival. BioVie is targeting ambulatory ascites patients (sometime overlapping with Type 2 HRS) who are severely ill and at risk of progressing to hospitalization with HRS-1. BioVie is trying to prevent them from progressing to Type 1 HRS.
Yes Gov, FDA orphan drug designation:
BioVie’s New Drug Candidate BIV201 Receives FDA Orphan Drug Designation for the Treatment of Hepatorenal Syndrome (HRS)
LOS ANGELES, CA / ACCESSWIRE / November 28, 2018 / BioVie Inc. (OTCQB: BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for liver disease, announced today that the US Food and Drug Administration (FDA) has granted an Orphan Drug designation to BioVie for terlipressin for the treatment of hepatorenal syndrome (HRS). BIV201 is a new drug candidate currently being tested in a mid-stage (Phase 2a) clinical study in patients with refractory ascites due to advanced liver cirrhosis. The Company previously secured an Orphan Drug designation for terlipressin for treating ascites, and is exploring additional Orphan designation opportunities.
"An estimated 12,000 to 33,000 Americans develop HRS each year," said BioVie CEO Terren Peizer. "Our novel drug candidate BIV201 could potentially become an effective treatment option for this condition." Two forms of hepatorenal syndrome are recognized, Type 1 (HRS-1) and Type 2 (HRS-2), which are categorized by deterioration in kidney function. While HRS-1 involves rapidly progressing kidney failure with a high probability of death (median survival time is only 2 to 4 weeks), HRS-2 is characterized by a progressive but slower deterioration in kidney function, with a longer survival time of approximately 6 months. The FDA has not approved any drug therapies specifically for treating HRS and it represents a critical unmet medical need.
An Orphan Drug designation typically provides 7 years of market exclusivity to the company that is first to obtain FDA marketing approval for the drug for the designated rare disease or condition. Additionally, the sponsor can benefit from certain financial incentives, including research and development tax credits. If the same drug has already been approved, the proposed drug needs to demonstrate clinical superiority to obtain Orphan exclusivity for the same indication.
About BIV201
BIV201 (continuous infusion terlipressin) represents a potential new treatment option for thousands of patients suffering from ascites, HRS, and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically for treating ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. In addition to Orphan Drug designations for ascites and HRS, BIV201 has FDA Fast Track status and US patent protection. For more information about BioVie, please visit our website: www.biovieinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its clinical trials.
CONTACT INFORMATION
BioVie Inc.
info@biovieinc.com
SOURCE: BioVie Inc.
The new SEC Form 4 filings (above) indicate that many of the preferred shares sold in July went to insiders in BIVI -- a sign of confidence.
not much volume of late
Stock price reminding me of a yoyo.
zzzzzz....
Zero volume, so far today (Friday 9/21)
We appear to just be marking time before the next news.
The form 4 and form 3 released today are retrospective, in that they report what happened a year ago, when Mr. Wieland acquired his shares.
All quiet for the moment in BIVI land
Just to clarify the new Form 3s and 4s being filed by BIVI management, these are catching up on reporting which probably should have been filed earlier. The ones I've seen have been for purchases as recent as May 2018 plus prior acquisitions. No new purchases thus far ... but we shall see what is ultimately filed.
I can only urge potential investors to do your own due diligence as to whether Biovie is a suitable investment for you. There are a number of filings BIVI has made with the SEC, which are available on their Edgar system. Just search through the company name or symbol, and read the material for yourself.
You are conflating different facts and shoving events out of sequence. Acuitas - the now 80 percent holder - did not hold shares when the vote was taken to sell an 80 percent interest with warrants TO Acuitas.
I would urge you and anyone else to read the SEC filings in date order.
Honda, I sure would buy some at 1.5 cents/share, but please establish for us longs what your specific interest in BIVI is. Are you long? Are you on a crusade to save us poor foolish longs from ourselves? Are you deliberately trying to supress the price? And for what purpose, other than to buy inmore cheaply.
It was clear that BIVI was short on funds and looking for more. It was also clear that Acuitas made an offer that BIVI's majority shareholders found acceptible.
Honda, My guess is that you want to buy in at a lower price.
Gov, You have been known to have that effect. lol
Seriously, when an entity steps in and ponies up the cash BIVI needed to move terlipressin along, in exchange for an 80 percent interest, they have faith in the product. Someone also apparently feels the SP is too cheap and wanted to ride along.
I am watching and waiting.
At $0.14, it looks like they are well on the way back. Watching closely.
Trial ongoing; drug is in use in Europe for other uses and is safe. Major investment by Acuity for 80 pct ownershup which diluted us but gave BIVI the cash it needed. They would not have stuck that cash in did they not see a major gain in the offing. Look at the sec.com/edgar filings.
And today, someone scarfed up some big lots of stock.
140k purchased so far today, with 100k in one lump
Average daily volume is 111k. Already 110k at 9:40. Someone wants shares.