Provention Bio, Inc. (PRVB)

[dinogreeves]

For me, always, if I see manipulation I will stick with it. BLP*H is the next one that will go, that one is also being manipulated, at least for the ones that I am watching. I also have IOV*A

[Goabgo]

Agreed it was heavily shorted during the last 3 months. My sympathy to those who got scared and sold. I almost was one of them.

[makinezmoney]

$PRVB: March $9 calls............ now up 150k%


WOOOOooooooooooooooohoooooooooooooooooooooooooo


GO $PRVB

[eur06]

Huge call !!!
Missed it unfortunately.
PRVB

[dinogreeves]

Well, it definitely paid off, this was suppressed on purpose for this day.

[TheFinalCD]

PRVB $24

[Goabgo]

Your guess was an understatement. 25 $ today!!

[dinogreeves]

Well, my guess was that Sanofi was paying 40% premium for this stock under the terms, which they invested 35 million dollars at price of $12.90. Obviously market makers are keeping it down to kill the call options for this week.

[derkampfer]

*Your

[derkampfer]

You’re opinion this goes up 40% in 3 days why?

[dinogreeves]

Book it hand over fist. $14-15 dollars by close on Friday and take it to the bank/

[dinogreeves]

14-15 dollars by Friday next week close. Book it.

[adamp]

Yeah, in case you're all wondering... it's moving today because of shorts covering. if they weren't, the only volume we'd have is dumping on the BID. no one buys this company. It has worldwide press, and it still can't find a buyer. this is all shorts. this pig will be under $6 by end of year.

[adamp]

What does it matter anyway. All this stock does is tank. Not a buyer in sight yet this is supposed to be a ‘breakthrough’ drug… whatever. FDA are a bunch of clowns. Everyone running for the door… yeah, great drug.

[adamp]

What does it matter anyway. All this stock does is tank. Not a buyer in sight yet this is supposed to be a ‘breakthrough’ drug… whatever. FDA are a bunch of clowns. Everyone running for the door… yeah, great drug.

[DewDiligence]

Tzield is a major breakthrough—maybe (NYT):

https://www.nytimes.com/2022/11/18/health/fda-type-1-diabetes-delay.html

There’s a dilemma vis-à-vis the right time to start therapy. If started too early—i.e. when the patient has detectable autoimmune antibodies but does not yet have damage to the pancreas—Tzield may not work. OTOH, if therapy is started too late—when damage to the pancreas has already occurred—the clinical benefit is reduced to some degree.

A further problem is that screening for autoimmune antibodies capable of causing T1D is rarely done unless a patient has close relatives already diagnosed with T1D.

[sokol]

After more reading and reflection, I think you are right that the license payments do not matter. Relative to the cost of treatment, for whatever it is worth, this is what one commentator had to say:

“Provention along with several advocacy groups is working to expand disease awareness and screening. This will help drive the second wave of sales to the broader at-risk population.

After months of working with key opinion leaders, advocacy groups, payers, doctors, and patients, Provention has settled on a wholesale acquisition cost of $13,850 per vial of TZIELD. Its 14-day treatment regimen is administered to patients through an IV in an outpatient setting to start, and will eventually be available at home too. The total cost of one treatment regimen is $193,900.

This price point reflects the perceived value from all of the stakeholders, including the payers that were receptive to covering it at this cost, that this game-changing medicine brings to patients.”

[adamp]

they have over 100M in cash and securities. i don't think any of that matters. What matters is that they're charging $200k for a treatment that doesn't even offer a cure, only a very short term delay of disease progression. I'm surprised the FDA even approved it, but i bought back in when they did, assuming they truly believed in this drug. Only PRVB can struggle to close even on a day they get a major drug approved. Every other pharma doubles or triples on this news

[adamp]

I have no idea. All i know is that this thing should have ran 200-300% today and all its been is dumping all day long. surprised we were able to get back to 8. The action is terrible. Shares coming out of the woodwork. no idea how this goes. This is supposed to be a major breakthrough and all i see is garbage. 50M shares should have traded today. Apparently, this is only a breakthrough in the minds of the employees of PRVB. Maybe we get a short squeeze and I'm out. I have a long history with this company. They underperform at every turn. It doesn't look like that is going to change anytime soon

[sokol]

Also, the drug is licensed from another co. that is due $60 million right now and other payments later.

[sokol]

So, whether this high priced treatment that’s not a cure will be covered by Medicare/insurance is a legitimate concern?

[adamp]

ok, so i'm hearing the $200k per treatment is spooking investors. And maybe it should. This drug doesn't cure anything. just delays a diagnosis for a year or so. the pricing is bad for a non-curative drug. seriously, if it's not one thing it's another with this company. every other pharma stock that gets approval of a novel drug runs several hundreds of percents

[adamp]

MMs manipulating this to take out the 7.50 calls. I had 2 people tell me this was going to happen today. I’m listening to the webinar, this is pretty solid.

[sokol]

The CNN article said “The treatment comes in a single 14-day course of infusions..”

[FooBarAndGrill]

$193,000 for 14 vials used in a 14-day prevention regimen. Is this a 1-time thing?

[FooBarAndGrill]

Webinar 8am (now):
https://investors.proventionbio.com/events?item=57

[adamp]

Let’s see how Ashleigh screws this up. Up 9% on approval of ‘game changing’ drug… something not right here, as usual for PRVB

[adamp]

Very little chatter on the message boards… here, yahoo finance…

[adamp]

Only up 9% in premarket… as usual with CEO Ashleigh, the devil will be in the details. We should be up 100%+.

[adamp]

Only up 9% in premarket… as usual with CEO Ashleigh, the devil will be in the details. We should be up 100%+.

[sokol]

Drug companies have been manipulating the price of insulin although insulin has been around for many years. This approval may be a step in the direction of some relief away from solely trying to manage type 1 diabetes. It is the first therapy approved for prevention of type 1 diabetes. I assume that the patients undergoing this biologic treatment will not be dependent or solely dependent on insulin? Hopefully, patients prone to type 1 diabetes will avoid all of the debilitating consequences resulting from this disease.

[adamp]

I've been following this a VERY long time.. took a massive loss when it use to trade at $20. I've very impressed that it got approved, i wasn't expecting that. I think you're right that there are probably some restrictions involved, but this shouldn't take away from the simple fact that this drug is going prime-time. PRVB is a ripe buyout candidate, as well. Options will create massive volatility in the very near short term, but in the end, this should be priced at several times what it is now. I hope the drug works. I listened to the FDA meeting a while back and wasn't overly impressed. It looks like enough people are optimistic about this to give it a green light. Again, I hope it does what it's supposed to do, and then some. Diabetes is a killer. The medical community, patients included, are desperate for some kind of breakthrough in this field. I hope this is it.

[FooBarAndGrill]

Go-to-market may involve some unknowns. Waiting for details.

[sokol]

Great news! I wonder if the FDA included some limitations in its approval. The stock is trading again after hours, but it has not jumped like I expected it would upon approval. Anyway, I think it will wind up being broadly prescribed for diabetes patients. Thanks

[FooBarAndGrill]

Approved!
https://amp.cnn.com/cnn/2022/11/17/health/tzield-teplizumab-diabetic-treatment/index.html

[FooBarAndGrill]

HALTED
https://www.nasdaqtrader.com/trader.aspx?id=TradeHalts#

[crudeoil24]

PT > 15.00 ( Jefferies Maintains Buy on Provention Bio, Raises Price Target to $15

Jefferies analyst Chris Howerton maintains Provention Bio (NASDAQ:PRVB) with a Buy and raises the price target from $10 to $15.

Latest Ratings for PRVB DateFirmActionFromTo

Aug 2021OppenheimerMaintainsOutperform Aug 2021HC Wainwright & Co.MaintainsBuy Apr 2021Chardan CapitalMaintainsBuy

[crudeoil24]

PRVB shares up after the company said it has entered into a co-promotion agreement with Sanofi U.S. for the launch of Provention's lead investigational drug candidate teplizumab.

The agreement enables Provention Bio to use Sanofi's expertise, capabilities and commercial resources to support the potential launch of teplizumab currently under review by the U.S. Food and Drug Administration, for the delay of clinical type 1 diabetes in at-risk individuals.

The company sees a user fee goal date of Nov. 17 for the Biologics License Application.

Under the terms of the agreement, Sanofi will commit commercial resources in the U.S, including diabetes field specialists, account directors, field-based reimbursement and medical science liaisons to expand the number of key healthcare professionals reached in the U.S. In exchange, Provention will reimburse field force-related expenses that Sanofi will incur in connection with commercializing teplizumab under the agreement.

Provention retains all rights to teplizumab and maintains responsibility for the commercialization strategy.

The company also granted Sanofi, in consideration of a one-time payment of $20 million, an exclusive, one-time right of first negotiation to obtain exclusive global rights to commercialize teplizumab for Type 1 diabetes indications in humans. Sanofi may exercise the ROFN, until June 30, 2023, with an option to extend within 2023 under certain conditions.


Write to Chris Wack at [e-mail]


(END) Dow Jones Newswires

[sokol]

Provention Bio (NASDAQ:PRVB) has appointed Christina Yi as Chief Operations Officer and Benedict Osorio as Chief Quality Officer, responsible for all aspects of quality.

Is PRVB ramping up for production in commercial quantities?

[sokol]

Provention Bio Appoints Jan Hillson, M.D., as Senior Vice President of Clinical Development - See announcement above. Clinical development includes the entire process of bringing a new drug to market. As best I can determine, the company has met most of the FDA’s concerns regarding teplizumab; however, it also needs to address the comparability of the drug being manufactured for commercial use and the product used in previous clinical trials. Provention, I think, plans to meet with the FDA in December about designing a study to resolve this issue. I feel confident this issue will be addressed to the FDA’s satisfaction, and the drug will eventually be approved. However, this last issue may take some time that takes us into the first quarter of 2022 before we definitely know for certain that all hurdles have been met.

[sokol]

Yes, I agree. This is definitely something that may be cured. Receiving a CRL from the FDA is not good news, but the impact varies. In this case, the company may in the next few months produce the additional data from a study with multiple doses (as opposed to the single dose cited here) and a higher dose (as opposed to the lower dose also cited here). Lastly, the FDA in the … “CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted to the BLA and confirmed the acceptability of the proposed proprietary name for teplizumab.”

[amarinbullfromchicago]

I think this isn’t bad news for the drug, just a messed up process (that’s easily fixable, as you said). If anything, confidence in the drug should be as strong or stronger.

It may get pounded for a few days, but I think the stock recovers into the next FDA process

[sokol]

“…. the FDA stated that a single, low-dose …. failed to show PK comparability.” What will multiple and/or higher doses show? “ The Company expects relevant additional PK/PD data being, or to be, collected from a substudy in patients receiving 12-days of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed T1D patients…”. The Seeking Alpha article indicated the company believes product quality has been addressed. Product quality should be easy to remedy. The only thing I am concerned about is what will the additional PK/PD data show? I will continue to hold for now. Biotech is volatile, and this is another example - look for anything that indicates that additional or higher doses may work?

It is often said that it is all about dosing. Designing the correct dosage regimen is important for achieving the desired therapeutic efficacy and avoiding undesired effects. Additionally, this is a biologic. Possibly the drug may work differently for different patients. The amount of dosing, dosing frequency, number of injections, and time to onset of effect, etc., are but a few factors involved in the administration of this biologic. Biologics, like many things, I think are complicated.

[amarinbullfromchicago]

Thoughts on CRL today?

[beambe]

https://www.marketscreener.com/quote/stock/PRECIGEN-INC-46353268/news/Precigen-nbsp-View-presentation-35574744/

[north40000]

“..the next big one...”? There is plenty to think about on that question, including a shortened meeting agenda and a majority vote of AdCom recommending approval. A further lengthy clinical trial with more patients is possible, perhaps a Phase 4 confirmation trial after approval. Death of 3 patients in the treatment arm is worrisome. I haven’t read the briefing documents yet, nor have I seen a transcript of the AdCom proceedings.

Anent T1-D, you may find interesting some data and literature that was posted in message # 117234 on the AMRN message board. The Reduce-It trial did not include enough T1-D patients to enable a firm conclusion whether EPA in FDA-approved Vascepa is useful in preventing or treating T1-D.

[sokol]

Gbola Amusa, MD, CFA Partner, Head of Healthcare Research at Chardan Capital Markets said Friday that there are too many uncertainties for the FDA to approve Teplizumab on July 2, and the FDA will want to see more results from the ongoing phase 111 study into 2022; However, he maintained a buy rating on the stock. I believe the share price of Provention will be volatile going forward.

[amarinbullfromchicago]

Hey north good to see you here. Deciding whether or not this is the next big one. What are your thoughts? July 2nd is the date we’ll learn more I guess. I think the fact the fda voted in favor, I thought the stock would be higher. We’ve seen this before...

[sokol]

It is small biotech, and all biotechs are complicated. Moreover, all are risky - whether long or short. What's more, likely to be highly volatile, which can be very good or bad for long or short options depending.

[north40000]

Scratch that—PDUFA date is July 2.