EQZ

IT professional by trade with a strong interest in tech. Hunting trades on the US & ASX Markets. Developed & maintain

[EQZ @JoeNezitic]

Mesoblast ($MSB / $MESO) has announced that the FDA has accepted its Biologics Application for filing in end stage heart failure patients with LVADs who are at risk of life threatening gastrointestinal bleeding. This is not an approval, but it is an important milestone because the FDA has determined the application is complete enough to begin its review.

The interesting context is that the underlying randomized clinical trial did not originally meet its primary endpoint (improving temporary LVAD weaning). However, the trial also generated data suggesting a meaningful reduction in major GI bleeding a complication with few treatment options in this patient population. Mesoblast has worked with the FDA to shift the regulatory focus to that outcome, and today’s filing reflects the FDA's willingness to evaluate the existing evidence for this specific indication. The next key is whether the FDA believes the current clinical data are sufficient for approval, or whether additional evidence will be required.

If they can demonstrate commercial success beyond pediatric aGvHD with Ryoncil, I believe the market will begin assigning greater value to the broader platform. Beyond this BLA, Phase 3 results for chronic low back pain are expected in 2027, with Crohn’s disease also progressing through the pipeline. It’s also interesting that inflammation sits at the centre of both the Crohn’s program and this GI bleeding indication, even though they are distinct diseases.

[EQZ @JoeNezitic]

@wealthmatica Think ZETA most but health data.

[EQZ @JoeNezitic]

PIQ.. looks attractive at current price but boy has this company failed to deliver..
Biosimilars: Dead in the water.
PromarkerD: Commercial flop.
PromarkerEndo: The deeper you look, the worse it gets.

A 75% catch rate in Stage 1 means a 25% false negative rate for early stage sufferers. So 1 in 4 women with early endometriosis will be told they are clear, ironically delaying the vital medical investigation they need.

Add the Ethnicity Bias in the current reference data, and the real world utility plummets outside their narrow validation cohort..

[EQZ @JoeNezitic]

@frankie62131700 I think PNS will sign a commercial deal.

[EQZ @JoeNezitic]

$SHG getting battered in this EOFY small cap sell off feels like a massive overreaction.

IMO - A lot of this is down to the macro environment, SaaS is a tough place to be right now, and the market is punishing small cap tech across the board.

Fact is PNS have been very vocal that the 3Dicom trial is delivering real world value by cutting duplicate scans, and that $3M Florida budget for the FIU imaging repository is approved. The infrastructure funding is locked in. I know skeptics want to see a 3rd party sign a contract to prove broader SaaS adoption, but management have stated inbound interest from US health plans and MSOs, with commercial discussions moving forward. If we don't see some news soon then I will reevaluate but I am going to add to my position for now.

[EQZ @JoeNezitic]

Attention is liquidity. Excellent phrasing.

[TechLead @techleadhd]

Why I Sold All My Bitcoin... it's over.

(Full video below)

[EQZ @JoeNezitic]

@StoicInvestors Ditto - good entry at this price.

[Ayo 🦅🔥 @tfbvngz]

This technology would be so nice 🥺

[EQZ @JoeNezitic]

@frankie62131700 I think PNS will extend a commercial deployment, the language they used from the trial was very positive so it would be somewhat contradictory if they didn't. I'd give it until the end of Q3, if no updates by then its a dead duck.

[EQZ @JoeNezitic]

@StoicInvestors Respect the honesty mate. We all have our losses.

[EQZ @JoeNezitic]

@frankie62131700 Its June mate. I'd give it a couple more months to see If we get an update on the PNS story.

[Tinny Logan @tinnylogan]

Matt Rife Gets Into Religion with an Aussie! 😳

[EQZ @JoeNezitic]

$CYP Cynata’s Phase 2 aGvHD trial showed no statistically significant difference between active treatment and control across the primary and key secondary endpoints, leading the company to terminate the study.

What makes this relevant to $MSB is that Mesoblast has already achieved what many MSC companies have been trying to do for years..demonstrate clinically meaningful efficacy and obtain FDA approval in GvHD.

For years it was argued MSC therapies were a “class effect” and that success would be easily replicated.

Today’s result suggests the opposite. Manufacturing platform, cell characteristics, trial design, and clinical execution clearly matter.

Cynata’s result doesn’t prove every other MSC program will fail, but it does highlight how difficult this field is and why MSB’s regulatory and clinical achievements should not be taken for granted.

[EQZ @JoeNezitic]

@asxpeasant Got it. So spreading racism is going to solve the problem. Nice

[JP__75 @JP__75]

Best city in the world.

Make no mistake.. this 👇 is the norm in Victoria now.. Labor want to distract you with sexism claims against the premier that’s responsible for all of this…
Melbourne is a crime infested shithole and it’s all happened on @JacintaAllanMP watch.

#auspol #springst

[The Stoic Investors @StoicInvestors]

$RNT is looking appealing

Robust Biz model with Aussie Propadee and rental demand.

Latest ann was🔥

2nd QTR of +OCF

On track for EBITDA Positive + DOUBLE Rev by Q2 FY27

Recurring Rev is 75% of group Rev

Diving in further thanks to @JoeNezitic we have some work to do.

[EQZ @JoeNezitic]

@StoicInvestors @Rentcomau @homelycomau The rentbond idea was a very smart strategy. Has given this a business a real turnaround story. I like it 🙌

[EQZ @JoeNezitic]

@asxpeasant All I see is an opportunity to make money.