Biocartis forum geopend

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tomtesteron
0
@Gijpie: hoe gaat het spreekwoord al weer? Vertrouwen komt te voet en gaat te paard ... ik vrees dat BCART een paar serieuze bevestiging nodig heeft voordat ze het vertrouwen weer kunnen herstellen.
Flatlander
0
ImmunExpress snags a grant to help roll out Septicyte Rapid in Australia. PR is sneaky in how it mentions that the grant institution has a $400 million budget while not mentioning the size of the grant.
FL

www.medianet.com.au/releases/release-...
Gijpie
0
@ Flat. For someone who is prepared to take a little gamble Tonix Pharmaceuticals on the Nasdaq . Their lead vaccine candidate against Covid 19 seems to have impressive efficacitie on animals. If they could optain a fast NDA this could be a big winner. They seem to be convinced because they plan on building 2 big factory’s to produce . Any thougts on this one Flat
Mil1999
0
@ Pumske

Ik ben nog maar sinds kort een poging aan het doen om de wereld van het beleggen wat beter te begrijpen. En van de link die je deelde begrijp ik al helemaal niet veel..

Iemand die misschien een beetje uitleg kan geven?
Gijpie
0
@ Mil Studie over het belang van PCR testing na Covid richting 2024 . Covid heeft aangetoond dat een precieze diagnose van patiënten steeds belangrijker word ook voor kanker ed. Ziekenhuizen zijn met de pandemie serieus overbelast geweest en hebben standaard ingrepen moeten beperken of verschuiven dan wordt een precieze diagnose zeer belangrijk. PCR testen halen het dan van traditionele methodes en al zeker in tijd . Die markt is zeer snel groeiend en is de core business van Biocartis ( vooral in kanker ) Alleen zien andere bedrijven dit ook en word de lijst met concurrenten heel groot . Biocartis had met zijn technologie een aanzienlijk voordeel op de concurrentie maar om de een of andere reden blijven goedkeuringen van verschillende instanties maar op zich wachten (FDA , Europa , Japan , China ) en wordt de grote doorbraak steeds verder in de tijd geschoven . Dus potentieel ja zeer zeker , komt het er ooit uit : who knowes
Flatlander
0
Mil
That research comes with a relatively steep price tag. There are other research reports that are free that have periodically been posted to this board. There were two sections of the report I'd love to see. The section on MDx moving out of the hospitals and the Appendix presenting assay reimbursement rates. Investors in BCART need to face the fact that NGS systems gets all of the press and the majority of the investment dollars. However, if you read the molecular pathology journal articles you can see that there is a synergy that rapid PCR systems can offer. The MSK presentation of EFGR emphasized this. So I think there will continue to be a place for both technologies.

As Gijpie mentioned, I do sense that BCART is at a turning point. The ramp period for launching assays cannot continue to push 3 years. The company realizes this and the FLEX initiative is directed toward expediting the process for content development partners. This is a start. They have shown that they can recognize a problem and move to fix it. They did the same with rectifying the Fisher distribution system issues. The next front I'd like to see progress on is the regulatory personnel to move products from RUO to full IVD approval. I see that many of the positions they are hiring for in the U.S. would include personnel that might help with regulatory approvals.

I'm resigned to wait things out another 12 months and reassess the progress at the end of 2021. Hopefully by that time there is more visibility on several fronts including:
- the EGFR - Tagrisso CDx
-the BMS -Optivo CDx
- the China, Japan and US registrations;
- the sales ramp of both consoles and cartridges coming out of the pandemic (there should be considerable pent up demand from delayed procedures;
-Maybe some news on the Kite gene therapy program would be nice;
-Some positive ICU user testimonials on Septicyte Rapid; and
-Of course, share price traction.

As I have said, the runway for this type of a system could be more than a decade starting at a very low base. Thus BCART could be a great long term holding if they can gain traction and execute. The number of oncology drugs with specific genetic targets grows significantly each year. If BCART can demonstrate to pharma partners that they can secure regulatory approvals for CDx assay products, they will be a sought out partner since they will help the pharma company capture a script before their competitors.

Have a Happy New Year!

FL
tomtesteron
0
Ik ben eens benieuwd wanneer Biocartis met zijn update gaat komen over het al dan niet halen van de 2020 doelstellingen. Vorig jaar kwam deze op 9 januari.

Ik denk / hoop :-) dat deze wel eens kan meevallen: ze gaven in een eerder persbericht bij de CE marking van hun COVID test aan dat deze in de eerste plaats gebruikt zou worden door één van de grootste analysecentra in Londen. Laat Londen nu meteen de plaats zijn waar COVID de laatste maanden van het jaar gigantisch hard toesloeg en waar de ziekenhuizen en ER's vollagen met COVID slachtoffers.


Flatlander
0
I'd expect a quick update within the next week. Management is on record as saying that BCART is at an inflection point in the growth trajectory. It would be nice if they provide a little visibility as to why they make that statement. Specifically what program/product will drive an uptick in growth. I have been on record as projecting that OncoTypeDx could be a killer App, to a lesser extent Septicyte Rapid and finally EGFR in Asia. To date, one program (Oncotype is dead). ImmunExpress missed their own deadline to release Covid Triage results by the end of 2020 and EGFR is waiting for the first registration approvals in Asia where the mutation is most prevalent.

As I mentioned on the board back in Sept. ImmunExpress has demonstrated that Septicyte rapid is equivalent to Septicyte lab. For that reason they should probably garner the FDA approval as occurred in the EU. The Covid Triage study is complicated. The bulk of the data they presented in September suggested some utility for use in triaging Covid patients. But the small dataset indicated there were nagging false positives and false negatives that they could not explain. The problem seems to be that intubation is not necessarily equivalent to sepsis. At the time they did not have access to all of the detailed patient records that might help determine whether the patient actually developed sepsis. Hopefully that has changed.

I no longer expect Septicyte Rapid Version 1 to be the Killer Ap we have been looking for. ImmunExpress has a four year collaboration with Novacyt (PrimerDesign) to develop a next generation Sepsis test. This program is pretty secretive as they and their competitor Inflammatix are both pushing hard on developing host-response assays for the ICU. Given the length of the program (since 2017) and the brainpower, this should be a product to really look for. Hopefully, it will be launched on Idylla.

So now I'm really looking for more information on the CDx approvals- the EGFR authorization for AZN's - Tasgrisso, MSI for BMS-Optivo-, KRAS for Amgen's product. The gene fusion panel should help with the lung cancer market. The sample size and quality is often limited so it is crucial that the majority of the actionable targets be evaluated from a sample. Gene fusion definitely helps fill out the offerings in the lung cancer area.

I would love for BCART to create a little splash and announce the gene fusion assay announcement at JPM. Don't think it will happen but I can dream that things get off to a better 2021 start. It is encouraging that so many presentations were introduced at AMP in November. This indicates that the RUO product is not sitting idle. However, this organic approach will take time. Ultimately, Idylla is competing against well funded giants. It is time to demonstrate traction or be acquired by someone who can better exploit some of the platforms advantages.

FL
Flatlander
0
Today it looks liken the US Senate control will flip to the Democrats as two Trump enabling Senators lose their re-election bids. The big question is whether all the damage can be repaired. The US used to be a force for promoting democracy throughout the world, now we narrowly escape our founding father's worst nightmare.

FL
CGCDLR
0
Blijkbaar begint de"stand still" enkelen deftig de keel uit te hangen.Je kan ze geen ongelijk geven!
tomtesteron
0
quote:

CGCDLR schreef op 7 januari 2021 10:35:


Blijkbaar begint de"stand still" enkelen deftig de keel uit te hangen.Je kan ze geen ongelijk geven!


Of zijn er die al meer weten ...
Flatlander
1
America is a big and diverse country. The moral center of the country has been shaken, These people who would take attack the Capitol are but a small fringe element. Trump has promised his followers he would "Make America Great" instead he proved that he could incite banana republic behavior. However, despite the chaos of yesterday, steps were taken to secure confidence. The people of Georgia voted out two of Trumps enablers and to that end the Country is truly grateful. Also, Biden's election win was certified guaranteeing that he will be sworn in on the 20th.

Now we as a Country must grapple with what actions will be taken against Trump. I suspect that we will find out that the Trump administration conspired with Capitol police to guarantee that they would not resist and in some cases aid the conspirators..

I look forward to a return to normalcy in 2021.
FL
Stefzele1
0
@tomtesteron, ze komen met een update op 10/01/2020 of wss maandagmorgen voorbeurs...
RUF RTR
1
Zoals zo vaak bij Biocartis zal er volgens mij zowel positief als negatief nieuws gemeld worden volgende week.Als men kijkt naar de Q3 business update was het cartridgevolume positief en de installed base een tegenvaller. Verwacht voor Q4 hetzelfde.
Neemt niet weg dat de huidige koersen meer opportuniteiten bieden dan risico’s.
Newbie7
0
Wat denkt u eerlijk? Zal deze positief zijn? Koersverloop laatste dagen voorspelt weinig goeds..
RUF RTR
0
Ik verwacht zelf dat ze de doelstellingen voor 2020 behalen mede dankzij hun SARS-CoV-2 test
Stefzele1
0
@Newbie, als Biocartis de verwachtingen naar boven bijsteld voor 2021 dan kan de koers van hieruit 15 à 25% stijgen...
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Vertraagd 2 mrt 2021 11:08
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