Gewinnerbranchen der Jahre 2006 bis 2040 (Seite 896)

[Rugier]

Also bei mir ist es die CVRS die einen schönen Ausbruch vollzogen hat, nicht CVRI😉
Einen schönen Dank für die Vorstellung von SENS und CVRS.

[clearasil]

Antwort auf Beitrag Nr.: 60.121.480 von ungierig am 17.03.19 00:02:22

eine Fahnenstange sieht anders aus. kommt vielleicht noch - bullischer Ausbruch aus längerfristiger Konsolidierung würde ich das nennen.

dran bleiben, das sieht sehr gut aus.

so viele interessante Unternehmen zur Zeit!

das muss im Zoo enden.

auch von mir: danke für CVRI.

[ungierig]

Antwort auf Beitrag Nr.: 59.970.358 von flying.kangaroo am 26.02.19 20:16:19

Dankeschön

für die Vorstellung, bin auf deine Vorstellung eingestiegen und die sind angesprungen, meine DNLI hat auch zugelegt, aber CVRI bildet eine Fahnenstange und ich bin an der Verankerung
Ärzte müssen keine schlechten Investoren sein

[clearasil]

neuester 10 K zu MRKR.
http://app.quotemedia.com/data/downloadFiling?webmasterId=10…" target="_blank" rel="nofollow ugc noopener">
http://app.quotemedia.com/data/downloadFiling?webmasterId=10…

Auszüge:

+++

In 2019, we expect to begin the technology transfer process and begin the planning and implementation of additional GMP manufacturing capacity capable of supporting our manufacturing needs with respect to pivotal trials. If the results of our Phase II studies are positive, we will explore potential avenues to achieve regulatory approval for the use of our products in these indications, including any potential avenues for obtaining accelerated approval. The U.S. Food and Drug Administration (“FDA”) may grant accelerated approval for product candidates used to treat serious conditions that fill an unmet medical need based on a surrogate or intermediate endpoint. We believe that an accelerated approval strategy may be warranted given the limited options available for patients with post-transplant AML. However, if the FDA grants accelerated approval, confirmatory trials will be required by the FDA.



· Continue collaboration with our partners and increase our internal research and development activities to improve and develop adoptive cell therapy technologies.



We finalized a strategic alliance with BCM, in which we will sponsor selected research at the institution in support of our technology. In conjunction with this strategic alliance, BCM will conduct selected Phase I/II clinical trials using our technology. If data from these early clinical trials appear positive, we will consider the therapeutic and commercial potential for such therapies to be advanced as new products for us.



In addition, we plan to use BCM facilities to enable the process development and manufacturing required to support the Phase II clinical trials of our product candidates. Outside of our relationship with BCM, we will invest in our own research and development and chemistry, manufacturing and controls (“CMC”) capabilities to enhance our ability to conduct process development to optimize our manufacturing process, product quality and commercial scalability.



We believe that the G-Rex® (G-Rex® is a registered trademark of Wilson Wolf Manufacturing Corporation (“Wilson Wolf:”)) based manufacturing process we have in place is highly robust and scalable, and we will continue to invest resources in further refining the manufacturing process to create a product with highly attractive commercial attributes. We plan to engage Wilson Wolf (a company controlled by John Wilson, a director of the Company) to further customize the G-Rex® to optimally match our manufacturing requirements and to develop a scalability plan to drive efficiencies for a commercial product.

+++

· Demonstrated clinical benefit, without the need for lymphodepletion before infusion: In BCM’s Phase I lymphoma study, we saw complete responses (“CRs”) in six of its evaluable patients, including three CRs in patients with diffuse large B-cell lymphoma (“DLBCL”). We believe it is significant that no patient with a CR has subsequently relapsed with disease, whereas typically 30% or more of patients with CR in reported CAR-T studies relapse within one year. In patient results to date, observed therapeutic responses appear to be highly durable, with some patients being relapse-free beyond five years.



· Non-gene-modified: Unlike CAR-T and TCR approaches, our therapy requires no genetic modification of T cells, a costly and complex process that significantly complicates the manufacturing of a patient product. We believe our therapy can be manufactured at a fraction of the cost of a gene-modified T cell product.



· Low incidence rate of adverse events: In 78 patients treated to date, BCM has seen only one grade III adverse reaction possibly related to its therapy. This appears favorable compared to published CD19 CAR-T studies, wherein up to 95% of patients had associated grade III or higher adverse events during treatment. There have been no cases of cytokine-release syndrome (“CRS”), or related serious adverse events (“SAEs”) in patients treated with our therapy to date.

+++ Capable of addressing a broad repertoire of cancer cells: While CAR-T and TCR therapies generally target a single epitope, our manufacturing process selects T cells that are specific for multiple peptides derived from several targeted antigens. Deep gene sequencing of the clinical products shows that a typical patient dose usually consists of approximately 4,000 unique T cell clonotypes targeting up to five different tumor-associated antigens. The five antigen targets can be recognized by a very wide range of T cells, facilitating robust killing of targeted cancer cells.



· Appears to drive endogenous immune responses: We see evidence of “epitope spreading” in the treated patients, meaning that the therapy is potentially inducing an enhanced response by the patient’s own T cells (specific for an expanded set of tumor-associated antigens beyond those targeted by the infused product). BCM’s correlative analyses show expansion of endogenous T cells, other than those present in our product, in the months following the infusion of our product. This phenomenon, also known as “antigen spreading,” is potentially important in generating a durable response for a patient, because it enables the killing of tumors that do not express any of the antigens initially targeted by our product.

+++ We believe that the use of human cells as a therapeutic modality to re-engage the immune system will be the next significant advancement in the treatment of cancer. These cellular therapies may avoid the long-term side effects associated with current treatments and have the potential to be effective regardless of the type of previous treatments patients have experienced.

[clearasil]

zu MRKR.

https://seekingalpha.com/article/4249159-marker-therapeutics…

[flying.kangaroo]

Antwort auf Beitrag Nr.: 60.113.599 von Tamakoschy am 15.03.19 18:03:42

Moin,

SENS scheint nochmal die Tiefs zu testen. Für mich Kurse zum Aufstocken:

Der weltweite CGM Markt wächst stark - dieses Jahr erwarten die Hersteller $ 3Mrd., was 50% YOY entspricht.

SENS hat schon die 180 Tage Version - Zulassung in Europa 2017. In den USA ist seit 2018 bisher die 90 Tage Version zugelassen.
In der Entwicklung ist ein 365 Tage Sensor, der wöchentlich nur kalibriert werden muss.

Vor einer MRI Untersuchung (Magnetresonanztomographie) muss der Sensor nicht mehr entfernt werden. Tim Goodnow (CEO) am 30.01.19: „Jetzt müssen Patienten, die Eversense CGM verwenden, sich keine Sorgen um eine Notfall-MRI machen oder eine geplante MRI auf der Grundlage ihres Glukosesensors verzögern. Alle anderen derzeit auf dem Markt befindlichen CGMs müssen gemäß den Angaben der FDA vor einem MRI-Scan entfernt werden."

Eine Zulassung als therapeutisches CGM wird Mitte 2019 von der FDA erwartet - dann entfällt die Fingerkuppenblutmessung.

Wird von immer mehr US Gesundheitsversicherern erstattet.

Das System kommt bei den Patienten sehr gut an - bisher nur positives dazu gelesen. Es gab sogar einen "Diabetes-Oscar" für die spannendste neue Diabestes Technologie https://www.healthline.com/diabetesmine/diabetes-oscars-2019…

Machbarkeitsstudie in Zusammenarbeit mit Beta-Bionics in der Eversense erstmals zur Kontrolle bei künstlichen Bauchspeicheldrüsen eingesetzt wurde.


--------------------


@Clearasil
Danke für dein positives Feedback zu AVH.

ASX:CYP auch schön angesprungen - dürfte nun langsam ernst werden mit FUJIFILM:

Fujifilm kauft Biogen-Produktionsstandort in Dänemark für $ 890 Mio.! Der Deal macht das japanische Unternehmen zur Nummer zwei im Bereich Biopharma-Auftragnehmer - hinter Lonza!!
https://asia.nikkei.com/Business/Business-deals/Fujifilm-to-…

cheers

[ungierig]

Antwort auf Beitrag Nr.: 60.113.740 von clearasil am 15.03.19 18:13:22

Würde sagen ja, durchaus Chancen. Patienten "lieben" Insulinpumpen und integrierte Messsysteme ist mein Eindruck. Menschen nehmen sich gerne wichtig und Selbstmessungen gehören dazu
Btw.glaube auch an regenerative Sachen und Stammzellen, gestern in einer Fachzeitung von einer Selbstverpflichtung der Anwendungsbeschränkung bei CRISP gelesen, dachte nur , schau mal nach einer Investition in dem Bereich

[clearasil]

Antwort auf Beitrag Nr.: 60.113.599 von Tamakoschy am 15.03.19 18:03:42

Zahlen ganz gut, schwacher Ausblick,stagnierende Umsätze angekündigt - vorsichtiges Management.

@all - Meinungen dazu, ob sich so ein Implantat durchsetzen wird/kann?

SENS arbeitet an der 180-Tageversion, was natürlich noch schöner wäre.

[Tamakoschy]

Antwort auf Beitrag Nr.: 59.977.147 von flying.kangaroo am 27.02.19 15:25:27

Sens

Nach Zahlen wieder im Rückwärtsgang:

https://www.marketscreener.com/SENSEONICS-HOLDINGS-INC-26786…" target="_blank" rel="nofollow ugc noopener">https://www.marketscreener.com/SENSEONICS-HOLDINGS-INC-26786…

[clearasil]

Antwort auf Beitrag Nr.: 60.100.302 von clearasil am 14.03.19 15:06:40

zu BLFS - erfreulicherweise gute Zahlen und Ausblick. Smarte, günstige! Aquise.

bemerkswert: nur 26 Mio Aktien überhaupt. Mittlerweile 33 mio cash.

ich bleibe dabei: regenerative Medizin und Stammzellen wird der Megatrend die nächsten Jahre werden.

https://seekingalpha.com/article/4248929-biolife-solutions-i…

2018 was a very strong year of execution and growth with revenue of just under $20 million. We grew the business almost 80% over 2017. Had our first full year of profitability and continue to make significant progress in driving the adoption of our proprietary, biopreservation media products in the cell and gene therapy market. I'll start with some comments about market dynamics and segment revenue and speak about our just announced agreement to acquire Astero Bio. After that Rod will present our Q4 and full year 2018 financial results and provide our initial guidance for 2019, including details around the expected financial impact of the Astero acquisition.

I'll begin with some comments about the Regenerative Medicine Market segment. First, 2018 funding continued at a torrid pace with more than $13 billion invested in the space during the year. This is up 73% over 2017. There were more than 1,000 clinical trials underway at the end of 2018. Our Regen Med segment revenue was $11 million or 56% of total revenue and representing growth of 108% over 2017. We gained 84 new direct cell and gene therapy customers in 2018. We also processed 57 additional cross reference request for our FDA master files. This is up from 27 in 2016 and 47 in 2017. This is a mechanism for cell and gene therapy customers to notify the FDA that they plan to use our products in clinical trials. Notable new 2018 direct customers include ALAgene, Flask Works, Maverick, [indiscernible], Mustang, POSEIDA, Rapa, Refuge [ph], Semma, Community and WindMil.

There is a new and very important dynamic occurring in the Regen Med space. The reimbursement environment for our prospects and customers is evolving into a pay on cure paradigm with payment predicated on a positive patient response to the therapy. We believe this dynamic will support broader adoption of our biopreservation media products, since this can de-risk the potential of delivering a non-viable dose to the patient. You've heard us say many times that dead cells don't cure cancer and the combined therapeutic and economic risk developers are facing should broad use of our products as a best practice in the manufacturer stores, distribution and administration of time and temperature sensitive cell and gene therapies. For the rest of 2019, some potential customer catalyst we are following include a conditional approval in Europe for Kiadis Pharma for ATIR101 adjunctive cell therapy for hematopoietic stem cell transplants. If approval is granted, Kiadis intends to launch ATIR101 in selected countries in Europe through its own commercial organizations starting in the second half of this year.