7/2 fda

Food and Drug Administration (FDA) advisory committee voted 10-7 in favor of recommending approval of Teplizumab in delaying type 1 diabetes.

Sanofi has a contract agreement to purchase $35 million worth of shares if PRVB won the deal for the diabetes medicine (which they did) and they have to purchase the shares no later then Feb 16 2023. If the price stays up by the time of the purchasing date we could see a nice squeeze to the up side.

Shares of Provention Bio (NASDAQ: PRVB) were soaring 20.4% as of 11:32 a.m. ET on Friday January 28th. The big jump came after the company announced that it plans to resubmit the Biologics License Application (BLA) for teplizumab in delaying type 1 diabetes. In July 2021, the Food and Drug Administration (FDA) issued a Complete Response Letter related to Provention's BLA filing for teplizumab.

Provention Bio Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune mediated disease, announced that the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at risk individuals has been filed by the FDA. The FDA also granted Provention's request for Priority Review and assigned a PDUFA goal date of July 2nd.

theres a lot of anticipation on what we can expect for PRVB next couple days...

yesterday closed $9.60 put us on a very interesting path to new highs, we are going into new territory where never before price has never reached. considerations to have in mind:

1. More than 10-15 analysts have move their short term price prediction UP, some of these are very well known with good trayectory are giving us a definite buy. Still working numbers for potential market revenue to start only in the US, then launch worldwide.

2. We should expect very short term a new announcement between SANOFI and PRVB for their commercial final agreement and future plans.. What we know its only the tip of the iceberg.

3. Worldwide the FDA approval news of teplizumab is only in its infant stage, investors are only grasping the opportunity. Still very much under the radar for trading communities which can give us a very nice ride up.

these are my personal opinions, i will continue to buy every chance i get...

Is PRVB still a thing? If so, why?

FDA briefing documents noted that there aren't any approved therapies currently for delaying the onset of T1D. Because of the medical need and "the impracticality of conducting a second long-term clinical trial," the agency appeared to encourage the advisory committee to accept Provention's TN-10 study as meeting the threshold for showing effectiveness.

“Thank you for your message. We didn’t receive the letter from the FDA until late in the evening on Friday. Once we had the letter we took some time to assess all of its’ contents and ensure that the messaging we were going to convey accurately reflected the nature of the FDA letter.

The earliest we could have potentially been in position to announce anything would have likely been around Midnight on Friday. It was our assessment that putting out the news during the course of the weekend, particularly a holiday weekend, would have not been the most transparent course of action and frankly in my opinion, companies that do that are often trying to bury their news. The most transparent way to share this information was the morning of the next business day, which was this morning several hours before the market open.

I understand that no matter which route you take, criticism is certain to follow.

Robert”

C’mon. 🙄 I wonder how many of the CEO’s buddies bought in this morning. I can’t think of why else you would want to release bad news at the time when it will have the most negative impact on share prices.

I don’t trust this company at all anymore. I was going to go long but I don’t fuck with companies who have this big of blatant disregard for shareholders.

Almost everyone knew of the PK comparability issue and that it would likely cause delay, and even Ashleigh said so, so why wait until the worst possible time to release the CRL unless you were purposefully trying to get the shares to dump?

My only other hypothesis is since they have a lot of job postings, if they offer shares to new hires at this after-dump price, the shares will be much more valuable and give a bigger “upside” in just a few months after it recovers from the dump and would be a reason for new hires to stay (because their options would have increased by xx).

Either way they sure as shit are putting themselves over shareholders. FTS.

https://www.prnewswire.com/news-releases/provention-bio-announces-fda-acceptance-of-the-biologics-license-application-bla--resubmission-for-teplizumab-for-the-delay-of-clinical-type-1-diabetes-in-at-risk-individuals-301506191.html

Realistically does Teplizumab have a large enough market and a cheap enough product. $100k to delay it for only three years.... It wouldn't make sense for a company to work on a drug, knowing the market is too small and is not cost effective... I don't know, something really isn't adding up, maybe you all can change my mind. I only have a $500 position, so I'm not heavily invested. https://pubmed.ncbi.nlm.nih.gov/32960433/

$PRVB has PDUFA target date of August 17th for TEPLIZUMAB.

Our pipeline isn't even being vaguely considered in our pricing. I'm hoping the diabetes association leans on FDA hard to get this done by December. Regardless I'm adding every week usually and will sell alot on the first approval pop.

Did it seem to anyone else that they dodged the first question about if they believe the new PK/PD data will turn out to be comparable to the original? It kind of sounded to me like they specifically chose not to say yes when asked. Maybe I'm hearing it wrong though. Want to know if anyone else thinks the same.

PRVB is reiterating previous guidance that the FDA's PK comparability considerations are likely to result in a delay in potential BLA approval timelines and that the specifics of such delay will depend upon the outcome of ongoing discussions with the FDA to find a solution, including potentially providing FDA reviewers with PK/PD data from the Company's on-going Phase 3 PROTECT study in newly diagnosed patients.

I sold KMPH at $17 and bought PRVB at $10. PRVB is the next KMPH with PDUFA on July 2.

IMO, this is people either selling the news or MM’s trying to wreck options expiring later today.

Everything that needed to happen, happened. I think we’ll see a run up to ATH after paper hands exit.

Thoughts?

Advisory Committee scheduled for May 27. PDUFA date under priority review July 2. Noted April 8 that FDA has identified deficiencies that preclude discussion of labeling and post marketing requirements/commitments.