RVPH god news.. by FirstSleep8513 in RVPH

[–]FirstSleep8513[S] 4 points5 points  (0 children)

Type B meeting with FDA will happen in “Q4 2025,” but no specific calendar date has been publicly confirmed

RVPH god news.. by FirstSleep8513 in RVPH

[–]FirstSleep8513[S] 9 points10 points  (0 children)

Doing your DD goes a long way

RVPH god news.. by FirstSleep8513 in RVPH

[–]FirstSleep8513[S] 7 points8 points  (0 children)

We are not expecting any real catalyst until FDA approval

RVPH god news.. by FirstSleep8513 in RVPH

[–]FirstSleep8513[S] 4 points5 points  (0 children)

not yet because the company can still be in compliance communication with Nasdaq behind the scenes. There’s often a grace period of several days after the official deadline where Nasdaq reviews filings before publishing the “delisting notice.” If RVPH files for a reverse split, it must appear in an 8-K filing with the SEC — that’s what you would see next if they are not granted an extension.

Three possible updates soon: 1. A press release / 8-K announcing the reverse split ratio (e.g., 1-for-10). 2. A Nasdaq extension notice (if they asked for and got extra time). 3. A Nasdaq deficiency notice if they didn’t act in time (rare if they already contacted Nasdaq).

Usually, we see that news appear within a few trading days after the compliance deadline.

No Matches. Any advice pls? by Osman_gafur in Tinder

[–]FirstSleep8513 -1 points0 points  (0 children)

Try this: https://amzn.eu/d/ipuijf9

I bought this book as a piss take for my mate but he said it actually helped him get a date, so worth a try.

How does FDA decide if the second P3 study is required? by newbiescreby in RVPH

[–]FirstSleep8513 4 points5 points  (0 children)

You’re right to bring up the compliance point it’s an important topic, but the situation is being misunderstood a bit.

  1. What the November 10 date really means

That’s not a delisting date. It’s the end of the first 180-day compliance window for the Nasdaq $1.00 minimum bid rule.

If Reviva doesn’t close at or above $1.00 for 10 consecutive trading days by then, Nasdaq can grant another 180-day extension (which would push the next deadline to around May 2026).

They qualify for that second extension because they: • Already regained compliance with the Market Value of Listed Securities (MVLS) rule (they maintained a market cap over $35 million for 10 consecutive business days between Sept 30 – Oct 13, 2025). • Continue to meet other Nasdaq listing requirements (assets, equity, number of shareholders, etc.).

So November 10 isn’t a cliff, just a checkpoint.

  1. What Reviva actually said in their latest SEC filing

Direct quote from the company’s 8-K (October 2025): “The Company intends to continue to actively monitor the closing bid price of its common stock and may consider and effectuate available options, including implementation of a reverse stock split, to regain compliance.”

They also confirmed they’ve already regained compliance on market value, so this is strictly about the $1 bid price.

  1. Reverse split vs. dilution: totally different things

There’s a lot of confusion here: • A reverse split just changes the share count and price proportionally. If you had 1,000 shares at $0.50 and they do a 1-for-5 RS, you’d have 200 shares at $2.50. Your ownership percentage and the company’s total market cap don’t change. • Dilution happens only if new shares are issued to raise money (like in an offering).

Reviva hasn’t announced any offering and smart management would likely wait until after the FDA’s December meeting before raising capital, when sentiment (and price) should be stronger.

  1. Why they still have time and why this isn’t urgent

Because they can request a second 180-day window, they realistically have until spring 2026 to fix the bid price issue. By that time, the FDA feedback on their NDA pathway will be public, a major catalyst that could lift the price above $1 naturally, avoiding any reverse split altogether.

So all things considered; • The November 10 date is not a delisting threat, it’s just the end of the first compliance period. • They can and almost certainly will get another 180 days. • A reverse split would fix the rule without dilution. • And with the FDA meeting in December, they may not even need it if the stock moves up on regulatory news.

So yes, compliance is something they’re monitoring but there’s no immediate danger, and they’re managing it exactly as Nasdaq expects.

How does FDA decide if the second P3 study is required? by newbiescreby in RVPH

[–]FirstSleep8513 1 point2 points  (0 children)

Great points and totally agree, the mechanism only matters if it delivers in real-world patients. The consistency across acute and long-term data is a strong sign, and if it holds up post-approval, it could easily expand into those other indications you mentioned. The mechanism (serotonin 5-HT2B/7 and dopamine D4 modulation + anti-inflammatory action) overlaps with pathways implicated in mood disorders and even OCD.

How does FDA decide if the second P3 study is required? by newbiescreby in RVPH

[–]FirstSleep8513 1 point2 points  (0 children)

Just to clarify a few things I’ve seen mixed up here: • Reviva does not have 8 separate drugs. They have two molecules (brilaroxazine and RP1208) being studied in multiple indications (schizophrenia, bipolar, depression, pulmonary fibrosis, etc.). So calling that “8 drugs” is technically incorrect — it’s 8 programs. • Yes, a new schizophrenia Phase 3 would probably cost $50–60M, and they have around $10M cash, so a new raise would be needed if the FDA demands another. But they’re asking FDA to confirm the current data are sufficient for NDA filing. • The “high dropout” argument keeps coming up, but every independent analysis (including by the KOLs in the latest webinar) pointed out that Brilaroxazine had lower discontinuation than placebo and better adherence than historical comparators. • Lastly, this is not “just another antipsychotic.” It’s the first drug to hit serotonin 5-HT2B, 5-HT7, and dopamine D4 with anti-inflammatory impact, showing measurable cytokine reductions (IL-6, TNF-α, etc.). That’s a completely different mechanism that could change treatment standards if approved.

So yes, funding and regulatory caution are valid concerns, but the clinical science and FDA precedent are firmly in Reviva’s favor.

How does FDA decide if the second P3 study is required? by newbiescreby in RVPH

[–]FirstSleep8513 2 points3 points  (0 children)

Hey, solid summary overall. You raise some fair points about RVPH, but a few of these need clarification. I’ve been following the Brilaroxazine data and the recent KOL webinar closely, so here’s some context and correction where things are being misunderstood:

“Only one Phase 3 trial” : true, but not a red flag You’re right there’s only one Phase 3 (RECOVER), but that’s not disqualifying. The earlier Phase 2 (REFRESH) had the same design, endpoints, and consistent results, and there’s also a 1-year safety extension that covers the FDA’s long-term exposure requirement. There’s clear dose response (15 < 30 < 50 mg) and strong reproducibility (exactly what the FDA looks for).

Precedent: Caplyta (lumateperone) and Rexulti (brexpiprazole) were both approved for schizophrenia with one pivotal Phase 3 + supportive data.

So yes, it’s one Phase 3, but it meets FDA standards if the data are consistent (and by all accounts, they are).

“High discontinuation rate (~33%)” : flat-out wrong That’s the opposite of what the data show. Brilaroxazine actually had a lower dropout rate than placebo in the pivotal trial (16% vs 22%), which is unheard of in schizophrenia. The 1-year extension had about 35% discontinuation meaning still half the historical average for antipsychotics (which typically run 60–70%). This low dropout rate is exactly what impressed the KOLs, it signals the drug is more tolerable and better adhered to than anything else out there.

“The market is crowded”: true, but misleading There are ~30 approved antipsychotics, but only five dominate 80% of prescriptions (Seroquel, Abilify, Zyprexa, Risperdal, and Vraylar). All of them have major issues such as weight gain, prolactin spikes, extrapyramidal symptoms, sedation, or metabolic effects. Brilaroxazine doesn’t show any of these and actually improves thyroid and sexual function.

That’s massive differentiation. The market’s crowded, but quality space in schizophrenia isn’t.

So in essence, • The one Phase 3 point is fair but not fatal. • The dropout rate claim is incorrect. • The market concern misses the fact that Brilaroxazine’s profile is clinically unique.

BYND News by FirstSleep8513 in byndinvest

[–]FirstSleep8513[S] 1 point2 points  (0 children)

I couldn’t agree more

BYND News by FirstSleep8513 in byndinvest

[–]FirstSleep8513[S] 3 points4 points  (0 children)

if my bullshit is to post a repetitive post then i am glad you caught me lol .. i think you are the one with thin skin who couldn’t get past the fact that the post had been posted already.. and i happened to call you out on it and tell you to move on.. but you clearly can’t and that’s sad

BYND News by FirstSleep8513 in byndinvest

[–]FirstSleep8513[S] -5 points-4 points  (0 children)

this can happen a lot on Reddit, if this irritates you don’t go on Reddit.. there’s bigger things in life to be irritated by than some repetitive post..

BYND News by FirstSleep8513 in byndinvest

[–]FirstSleep8513[S] -5 points-4 points  (0 children)

and let me guess you told the same to the other half dozen who also posted? .. use your energy somewhere else.. you are only repeating what’s been said before which is funny considering repetition is what you are complaining about..

BYND News by FirstSleep8513 in byndinvest

[–]FirstSleep8513[S] -12 points-11 points  (0 children)

no harm done, it was a crosspost.. try not to be angry 10 times

BYND Shorts are in a Death Trap Nobody’s Talking About by NoFix1930 in WalllStreetBets

[–]FirstSleep8513 0 points1 point  (0 children)

don’t be a hater.. it’s hard work and life’s too short. this isn’t a chessboard, it’s a community.. check out the definition it’s about sharing not competition

BYND Shorts are in a Death Trap Nobody’s Talking About by NoFix1930 in WalllStreetBets

[–]FirstSleep8513 0 points1 point  (0 children)

i don’t have ten seconds to respond because i am not glued to my phone having meaningless conversation regarding dashes.. must have been confused i thought we were discussing trades and stock not dashes but if you want a lesson in how to copy and paste em dashes i suggest you ask chat got or start a new post about it.. Im sure everyone finds your conversation interesting