Still holding and considering to add soon.

$HEPA
Just so everyone knows that AKRO is starting a 2b Trial for NASH with Fast Track Designation, but has a greatly inferior drug, yet is trading at $20+ with PT in $60+.

So to be comparable, although CRV431 is a much more superior drug WITH MULTIPLE OTHER INDICATIONS, HEPA’s stock should be trading at $10+ with PT of $30+ just to be equally valued…when CRV431 is vastly more valuable!!!

Posted on ST

$HEPA FDA consider crv431 a drug with excellent efficacy and safety profile to potentially treat Nash. A very good support from FDA to Hepion.

$HEPA (+13.9% pre) Could easy go 50-100% today!!!

Lets toast the criminals and move this up 50-100% today, and force them to cover. Short squeeze!!!

$HEPA , Fast track is GOOD news..

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy

Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

Ability to address emerging or anticipated public health need

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

$HEPA news....

Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH Hepion Pharmaceuticals, Inc.
EDISON, N.J., Nov. 30, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for the Company’s lead drug candidate, CRV431, for the treatment of NASH.

The FDA Fast Track designation allows sponsors to gain access to expedited drug approval reviews for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need. The program is also designed to facilitate drug development by making provisions for more frequent meetings with the FDA to discuss drug development plans, and Fast Track designation can lead to Accelerated Approval and/or Priority Review eligibility if certain criteria are met.

“CRV431 has been investigated in healthy subjects during our Phase 1 program, and more recently in subjects with presumed F2 and F3 NASH in our Phase 2a AMBITION study,” commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “Administered once daily as an oral soft gel capsule, CRV431 has been well-tolerated and has shown signals of efficacy in NASH in this early Phase 2 study. We are now looking forward to initiating our larger Phase 2b NASH study, called ‘ASCEND-NASH’, in biopsy confirmed F2 and F3 NASH subjects in the coming months.”

Dr. Hobbs continued, “We are keenly aware that there remains an urgent global need to develop NASH-specific therapeutic drugs for this potentially life-threatening condition, for which there are currently no FDA approved drugs. Furthermore, the American Liver Foundation estimates that at least 5% of the U.S. adult population has NASH. As such, we are very pleased to receive the FDA’s Fast Track designation and are looking forward to working closely with the Agency as we advance development of CRV431.”

Robert Foster, PharmD, PhD, Hepion’s CEO, added, “This Fast Track designation provides for early and frequent communication with the FDA that will continue throughout the drug development and review process, which may lead to a more expedited drug approval and patient access to CRV431. Additionally, as part of the FDA Fast Track designation for CRV431 in NASH, Hepion will make its expanded access policy publicly available in the coming weeks.”

$HEPA load the boat we are ready to lift off!!!

Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH Hepion Pharmaceuticals, Inc.


https://www.stonkmoon.com/news/HEPA/48b86544f281dfa4cad0def45bc9fcfa

Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH Hepion Pharmaceuticals, Inc.

Just hold and add. I think it will do a big run in 2022…

Added @ $1.31 my. Avg is now $1.90 :)

Yes still here. Diamond hands

Hopefully he still holds this GEM. I hope for him. We will make money , just be patience. I added more today now my avg. is $1.99

“Enough cash on hand to cover all costs of programs through end of Phase 2b (about 3 years in cash), assuming no expansion into other areas/projects”

Their words not mine

I don't know what happens here, we are at liquidation value right now. Incoming events, coming tuesday just a simple convention, and in November a full data readout.

Maybe M&A will happen, maybe not, we just don't know. Just stick to the potential of the science, that's it guys.

There is not a big risk of dilution, certainly not after the result of the vote.

It's clear that their initial target was to have 400m shares issuable, so they could issue the 320m shares on the shelf for the maximum of 350 million dollar they were cleared to. Let's say $1.10

Next play was the 240m shares issuable, so they had 160m shares to offer for the max of 350m dollar. Let's say $2.20

Now they have only 40m shares left to offer, for the max of 350m dollar. Let's say $9 bucks.

Conclusion, I don't know whether M&A will happen, maybe the ''Change of Control'' thing has to do with something else. Fact is, the potential here is HUGE, and the risk is LOW.

Low Risk, High Reward, as Warren likes 'em.

$HEPA

No no.. still Holding almost 5k shares @ 2.09 avg.

Guess we just vote NO ?

Filled gap.. now we can rise :)

Patience is key here… stay strong

Todd is on the CC now..

listen to the event here: https://edge.media-server.com/mmc/p/cxdssmij

$HEPA

Fress Check this...

Travis Fisher and Kevine Donahoe both "liked" Hobbs linkdin post about the conference call....both dudes are top execs at Novo..hmmmmm. BOOM!

$HEPA

Every study I’ve read containing CRV431 has been overwhelmingly positive! Something big is coming….

go $HEPA

$HEPA Long and strong diamond hands. Monday's price action should be interesting.

$HEPA "it would not be strange to see Hepion's Market Cap surpass $1 billion." That's $13+ per share target folks!

$HEPA
This is the guy with $13 outlook. Wonderful ranking on seekingalpha
https://twitter.com/Ultra_Calls/status/1435659979495813124

$HEPA Global Nonalcoholic Steatohepatitis Market $20 Billion by 2027
https://www.ihealthcareanalyst.com/global-nonalcoholic-steatohepatitis-treatment-market/

$HEPA
expects to release additional data from its Phase 2a ‘AMBITION’ NASH clinical trial before the market opens on Monday, September 13, 2021. As previously disclosed, all primary endpoints were achieved in the trial. #NASH

$HEPA
#NASH Holy grail, Market in billions. @25 it will be 2 billion in market cap.
Dr. Hobbs will help lead Hepion's engagement with the U.S. Food and Drug Administration ("FDA"), global and national thought leaders, key policymakers, and professional associations.

Looking good… go $HEPA

$HEPA There are 76 million HEPA shares outstanding. >95% institutional ownership.

No filings were submitted for ~70% of the 64 million shares bought at the November and February offerings, meaning the vast majority was concealed. Before institutions bought 64 million shares at those offerings, there were 12 million shares out, with 3 million in the public float.

So, direct holders had ~9 million shares of that, and tutes got 64 million shares at the offerings, which possibly left ~3 million shares for retail then.

Also the chart just reversed.

Company has 120 million in the bank burning under 5 million a quarter!

$HEPA ready to bounce from the bottom $2 breakout this week IMO

SOME DD DONE BY A COMMUNITY MEMBER. Nfa.

Every single thing you need to know about it.

Shoutout to r/BullSeed4PuffBears

BBIG reverse merger has way more upside than SPRT. The fundamentals are also way better than sprt..for the reasons below.

Lomotif is the rival to Tik Tok And has an average of 31 Million users per month. By April, 2022, it will reach 600 million users. CEO video with Ted Farnsworth starts at 14 mins.

They are spinning off emmersive entertainment which is their NFT platform and whoever is holding shares of BBIG gets a 1:1 split of emmersive stock as well. This stock has been rumored to be valued at $2-$3.

BBIG has the proxy coming out any day now.

Let's do the math. If SPRT hits $100 that's 3.5x from current price.

BBIG fair value is at $35...4x of current price. Add in that it's 40% short... It could easily run to $70 making it 7-8x.. SPRT would have to hit $200+ for the same return... It's not happening.

There is 60 million shares from Vinco and 44 million shares from Zash, that’s 104 million shares in issue.

104 million shares x 2.85 dollars is currently a MARKET CAP of around 300 million dollars for Vinco, Zash, & Lomotive. That’s what we are currently valuing everything at.

The market has YET to factor in that we own 80% of Lomotive which has an independent valuation of 5 billion dollars. 80% of 5 billion is 4 billion so we can add 4 billion on top of 300 million.

So we are now at a Market Cap of 4.3 BILLION DOLLARS. So 4.3 billion divided by 104 million shares is around $38.

That’s the fair share price... $38

Hope this helps and stop listening to people who have no clue and can’t hold stocks for more than a day.

20 million Warrants exercised at $9 for BBIG

Ask yourself - why would an investor do that?

It would’ve cost a lot more to buy shares on the open market. Therefore, it is an 198 MILLION DOLLAR bet that the stock is going way up.

Short squeeze, volume increase, upward trend and proxy news are all great. BUT an 18m investment at $9 per share is well enough conviction in itself.

They also just added $22 strikes to the option chain.

I also currently believe that some institutions don’t want the word on this spread. This entire week the day has ended with around 250M volume. Funny how everyone isn’t all over this right now. Today BBIG ended with 300M volume, but when you go on yahoo finance and look at the top volume stocks for the day, BBIG isn’t on there even though it exceeded first place by a long shot. A lot of volume could’ve also be from shorts though.

Here is info on the merger. Vinco Ventures (BBIG) and ZASH Complete Acquisition of Lomotif. /r/pennystocks/comments/pg4fzr/vinco_ventures_bbig_and_zash_complete_acquisition/?utm_source=share&utm_medium=ios_app&utm_name=iossmf

$BBIG - https://media.discordapp.net/attachments/543613966728036381/882807025753522216/Screen_Shot_2021-09-01_at_9.59.15_PM.png

https://gyazo.com/a3626f2ee74fc227f48c379b53fdeda5

https://www.streetinsider.com/dr/news.php?id=18891144

Buy rating /r/BBIG/comments/pg5gzc/160000_calls_itm_now_vs_137000_from_yesterday_now/?utm_source=share&utm_medium=ios_app&utm_name=iossmf

This video goes further into the numbers. /r/Shortsqueeze/comments/pflj9l/bbig_options_chain_has_the_potential_to_create/?utm_source=share&utm_medium=ios_app&utm_name=iossmf

More DD /r/Shortsqueeze/comments/pf4dax/bbig_dd_as_requested/?utm_source=share&utm_medium=ios_app&utm_name=iossmf

Deal with universal music https://completemusicupdate.com/article/tiktok-rival-lomotif-signs-licensing-deal-with-universal/

What are Stock Warrants and what they mean for BBIG Shareholders (from a CPA)

Seeing a lot of questions regarding the recent stock warrant issuance so I thought I would share a little background based on my knowledge in the Capital Markets with Deloitte.

**Background:** A stock warrant represents the right to purchase a company's stock at a specific price and at a specific date (similar to an option w/ no obligation and typically expiration dates). A stock warrant is issued directly by a company to an investor. There are times when warrants have vesting periods. A warrant is typically provided as a part of a deal as a "kicker" to sweeten the deal by granting participants the right, but not the obligation, to acquire stock in the company at a set price, by a given date.

See below for an exceprt from the recent proxy filed on 9/1/21 (NOT REVERSE MERGER RELATED).

"*(i) the Investor shall exercise warrants that were issued on May 24, 2021 and are currently held by the Investor for 6,900,000 shares of the Company?s common stock, par value $0.001 per share (the ?Common Stock?), at the exercise price set on May 24, 2021; (ii) the Company shall issue and deliver to the Investor warrants to purchase an aggregate of 20,000,000 shares of Common Stock at an exercise price of $9.00 per share, subject to adjustments provided therein (the ?September Series A Warrants?); and (iii) the Company shall issue and deliver to the Investor warrants to purchase an aggregate of 2,000,000 shares of Common Stock at an exercise price of $9.00 per share*"

**Proxy Explanations:**

(i) Represents the Investor EXERCISING their Warrants in return for 6.9M shares @ X Price (SHARE DILUTION)

(ii) BBIG is issuing additional warrants to the Investor for 22M shares with an exercise price of $9.00 (This would be BEARISH at the time the warrants are exercised as it would further DILUTE SHARES). BBIG did not just buy 22M shares at $9. If this were the case we would've seen a massive cahs inflow for the stock.

Hopefully this helps and clears up some of the air regarding this recent proxy filing and a portion of the reasoning as to why we just saw a massive dip from today's highs (share dilution + shorting).

**SUMMARY** \- SHARES ON DISCOUNT FOR NOW, BUY AND HODL FOR MORE BANANAS. NOT FINANCIAL ADVICE

$BBIG b000m

$PULM , just added some more...

This is great news … spread the word!!!

https://uspto.report/patent/app/20210260153

I think some have sold for a loss, but I will wait. I like their data from CRV431 and we should hear more soon...

$HEPA ...
I´m holding strong with $2.08 avg. not going to sell before multi dollars.
Strong hands LT play here..