ZVRA Zevra Therapeutics Inc

$ZVRA Intrabio worth 2bn and we are @ a 600mm market cap inclusive of cash? Unreal - This thing always the bridesmaid no matter how white the dress

$ZVRA FDAs Rare Disease Framework Initiative "The FDAs new Rare Disease Framework Initiative is a thoughtful, ambitious, laudable effort to build a regulatory structure that systematically supports rare disease therapeutic development & review, according to Hyman Phelps & McNamara lawyers." "Its central promise is to make fit-for-purpose evidentiary expectations the norm for rare diseases. FDA intends to build a framework in which advice & decision-making are consistently tailored to the evidence reasonably attainable given the disease, its onset, progression, the patient pop & its needs, & the investigational product – & clearly communicated throughout development & review. We hope this means sponsor-FDA discussions will begin with an open consideration of the approaches appropriate to the disease and product, rather than presumptions favoring conventional development sequencing, randomized controlled trials, or traditional statistical thresholds that sponsors must then seek to rebut.

$ZVRA The NBI & IBB are getting hit today, I think mainly due to the fear of higher interest rates; stocks took a turn when Fed announed that more rate hikes will be needed. ZVRA is in a unique position where it DOES NOT need CASH! Thus no financing concerns! This is just a market interest rate reaction selloff.

$ZVRA A possibility : If IntraBio had multiple suitors , there is a possibility that the other contenders may come to ZVRA. Only time can tell.

$ZVRA down almost 4.00 in the last 6 months what a disaster by tbis ceo he should be fired and the whkle damn board.

$ZVRA with even semi-competent management and board, this is easily in 20s. Instead we have Tamara, Neil, and the "blue vote" guys (who have done jack shit for investors since they wasted a shit ton of money on proxy votes). We can't hold $11. CAN't wait until I hit my price and bail on this circus of a management team. Too bad, because there was some good science here before it became Neil's piggybank

$ZVRA Way to go Neil! Really thinking in the best interests of the shareholders. If I did my math correctly, you cost us about $61,000,000 in market value with your tiny sale. I wonder what the Board thinks about that? And I bet he got a few calls from an institutional holder or two. Now is not the time to be cashing in unless you are required to for some reason. But where is your explanation?

$ZVRA Last week, nice move up in price on no apparent news. Then it came out that we are going to get our re-review from CHMP this week. OK, the move up made some sense that investors may be speculating on a different result. This week, big selling. Maybe they are realizing that we can't present any new information and Neil hasn't addressed the CHMP panel's concerns sufficiently. Whatever the reason is, we are being reminded that this is still ZVRA and Neil is in charge.

$ZVRA Maybe it's some kind of tax sale. But wouldn't it be nice to hear some kind of explanation. But don't ever expect Neil to do anything of benefit for us low life retail investors who have supported this company for years.

$ZVRA Because the EMA statutory clock for re-examinations allows up to 60 days from the re-examination request to form an opinion, assigning an AHEG in October aligns directly with issuing a final decision during the December 7–10 plenary. We can at least anticipate both asset overhangs being resolved by Christmas. 🎅 🎄

$ZVRA Seems like we're running against the XBI rather that tracking it like we normally do. I wonder if the market finally realizes that If Intrabio was worth $2B, ZVRA is way undervalued and must be worth at least half that regardless of EU approval or not. That would put us at $14.50 at least. Let's see if they let it start to rise to $14-$15 level without a smackdown. Then pray for good Q3 earnings and a positive EMA recommendation and we may finally get this over $20 so I can get out.

$ZVRA Just reality check laugh: Our pps is about the same as it was before Miplyffa was FDA approved, before $260M+ in cash reserves, before the $6.50 warrants were wiped out, before the legal issues were resolved, before Miplyffa was almost approved for toddlers as well, before a successful Type C meeting with the FDA, before a temporary worldwide partner in Ireland and I could probably keep going. KNOW WHAT YOU OWN.

$ZVRA I realize many have had their attention on CHMP and possible EU approval. However, to me the bread and butter is right here. Q3 is in the books, and next month we should find out how ZVRA did. It's very important that as revenues increase, we keep expenses down for better EPS. If expenses go up as much as revenues, then we really gained no ground, and the stock price will remain about the same. If we can get increased revenues with expenses about the same, I expect the stock price to move upward. How much depends on the numbers.

$ZVRA this is zrva, we have been here before...this is loading zone time. It used to be in the 4's, don't kick yourself later for not loading here

$ZVRA RFL data was not great. They can say an NDA is scheduled, but the FDA still needs to accept it with the current data and failed endpoint. I am not sure the FDA will accept the submission. 30% probability of rejection. RFL also went out of country for the majority of their data. FDA screens international data closely (or not at all) because the data is usually cooked. Trial Standards are less likely to be kept. If an NDA is submitted and accepted in Dec '26, it is still a year+ before the decision - Say early 2028 for a yea/na by the FDA. Lastly, the 30+ USA NPC patients in the RFL trial, are now open to request treatment from ZVRA....... Tutes are not selling..... neither am I, under 28

$ZVRA Approximately 50% of the market cap is cash which continues to grow with zero debt. The market is basically saying that Miplyffa which will generate $155M this year and approximately $175M next year and has 10 years plus of exclusivity, is worth only $300M. It also gives Celiprolol zero valuation. Hard to fathom.

$ZVRA next catalyst is in 1.5months, for 3Q ER. Not expecting much between now and then. Let’s hope it’s again a beat!

$ZVRA Here is the CEO's Form 4 filing https://www.sec.gov/Archives/edgar/data/1434647/000143464726000075/xslF345X06/wk-form4_1791923065.xml • 50,000 RSU's vested on Oct 10. • In accordance with his 10b5-1(c) plan from March 2026, he sold 20,000 shares after the RSUs vested, at an avg price of $11.2474. • After the RSU vesting and sale, he still owns 417,225 shares. • The RSU's were issued a few years ago. 25% vested each year, on October 10, 2024, October 10, 2025 and October 10, 2026. The remaining 25% will vest on Oct 10, 2027, so we will likely see a similar transaction next year.

$ZVRA There's no volume. Seen these moves how many times? Story remains the same. $275M in cash(earning interest), no debt, and cash flow positive. Subtract the cash, and the Street is valuing the company at $325M. That puts a pretty good floor under the stock price. Buyers of these unexplainable dips make money every time. This time should be no different.

$ZVRA Hmmm, low volume, up green today fighting against a red tide. Very interesting. Somebody thinks something is happening.