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Endless schreef op 1 mei 2019 15:12 :
[...]
Rtlz beursinside op de iexdag juni 2018. Zie you tube. Hier had hij het over 10x de toen huidige koers 80 euro en in de presentatie in de zaal 10-20x keer de huidige koers. Tot nu toe vertelt hij geen sprookjes al jaren komt uit wat hij zegt.
Moet er wel 2-3 blockbusters inzitten. filo is alvast 1
Hij had het over bedrijfswaarde, da's toch anders dan de waarde van de aandelen.
Volgens hr. O vd Stolpe EUR 500 in voorjaar 2022
Better Buy: Vertex Pharmaceuticals vs. Galapagoswww.yahoo.com/finance/news/better-buy...
winx09 schreef op 2 mei 2019 16:15 :
Better Buy: Vertex Pharmaceuticals vs. Galapagos
www.yahoo.com/finance/news/better-buy... Verdict As a pure growth play, Galapagos should turn out to be the better pick than Vertex. Vertex's valuation simply isn't attractive at this point -- even with its high-value triplet combo for cystic fibrosis nearing a regulatory filing. Galapagos' enterprise value, on the other hand, is only about three times the company's current cash position. With a robust clinical pipeline and a marquee partnership with Gilead in hand, Galapagos' stock is arguably a steal at these levels.
Transcript Conference Call Gilead:seekingalpha.com/article/4259400-gile... Meeting met FDA by midyear: We'll be able to file in Europe in the second half of this year, and we'll go and have a discussion now with the FDA. We've requested that meeting where we'll sit down and talk with them about what we have in terms of data from the MANTA studies what we have in terms of our Phase III registrational programs and what we should do. And the time the time lines around that will play out during that meeting. But look I think it's important to us and Dan has brought this with his fresh eyes on the program recently is that there is some degree of urgency for us to get this drug approved as quickly as we can and obviously in collaboration with the regulators across the world. A – Daniel O'Day No, I would just -- thank you John. I would just add Brian that I think it's, yes I've been impressed by the profile of the product through all three FINCH studies and the consistency and the outcome and the results on both the efficacy and safety side. And knowing that rheumatoid arthritis patients are waiting for highly efficacious medicines that also have good safety and tolerability profiles. I think, we're looking forward to the totality now the discussion with the FDA. So we put the request for the meeting. We expect to have that meeting by midyear and we'll be looking forward to getting back to you on kind of the next steps. But we remain bullish on this and looking forward to bringing this as soon as possible to patients around the world and in the U.S.
Lama Daila schreef op 3 mei 2019 06:45 :
Transcript Conference Call Gilead:
seekingalpha.com/article/4259400-gile... Meeting met FDA by midyear:
We'll be able to file in Europe in the second half of this year, and we'll go and have a discussion now with the FDA. We've requested that meeting where we'll sit down and talk with them about what we have in terms of data from the MANTA studies what we have in terms of our Phase III registrational programs and what we should do. And the time the time lines around that will play out during that meeting. But look I think it's important to us and Dan has brought this with his fresh eyes on the program recently is that there is some degree of urgency for us to get this drug approved as quickly as we can and obviously in collaboration with the regulators across the world.
A – Daniel O'Day
No, I would just -- thank you John. I would just add Brian that I think it's, yes I've been impressed by the profile of the product through all three FINCH studies and the consistency and the outcome and the results on both the efficacy and safety side. And knowing that rheumatoid arthritis patients are waiting for highly efficacious medicines that also have good safety and tolerability profiles. I think, we're looking forward to the totality now the discussion with the FDA. So we put the request for the meeting. We expect to have that meeting by midyear and we'll be looking forward to getting back to you on kind of the next steps. But we remain bullish on this and looking forward to bringing this as soon as possible to patients around the world and in the U.S.
Hoe duidelijk willen we het hebben?
Geneve schreef op 3 mei 2019 07:29 :
[...]
Hoe duidelijk willen we het hebben?
Idd, prima woorden!
Lama Daila schreef op 3 mei 2019 06:45 :
Transcript Conference Call Gilead:
seekingalpha.com/article/4259400-gile... Meeting met FDA by midyear:
We'll be able to file in Europe in the second half of this year, and we'll go and have a discussion now with the FDA. We've requested that meeting where we'll sit down and talk with them about what we have in terms of data from the MANTA studies what we have in terms of our Phase III registrational programs and what we should do. And the time the time lines around that will play out during that meeting. But look I think it's important to us and Dan has brought this with his fresh eyes on the program recently is that there is some degree of urgency for us to get this drug approved as quickly as we can and obviously in collaboration with the regulators across the world.
A – Daniel O'Day
No, I would just -- thank you John. I would just add Brian that I think it's, yes I've been impressed by the profile of the product through all three FINCH studies and the consistency and the outcome and the results on both the efficacy and safety side. And knowing that rheumatoid arthritis patients are waiting for highly efficacious medicines that also have good safety and tolerability profiles. I think, we're looking forward to the totality now the discussion with the FDA. So we put the request for the meeting. We expect to have that meeting by midyear and we'll be looking forward to getting back to you on kind of the next steps. But we remain bullish on this and looking forward to bringing this as soon as possible to patients around the world and in the U.S.
Quote: "We've requested that meeting where we'll sit down and talk with them about what we have in terms of data from the MANTA studies" In mijn optiek wordt hier gesproken over unblinding, uitlezen & analyseren van data door sponsor Gilead, van de MANTA studie. Tussentijdse resultaten van x aantal patiënten die 13 weken zijn behandeld. pe26 Aantal stappen tot NDA: 1) unblinding data MANTA studie: 13-weekse data analyseren van deelpopulatie 2) rubriceren en statistisch verzamelen 52-weekse data FINCH 1 en FINCH 3 safety data. Dit is nu onderhanden 3) Midden 2019 pre-NDA meeting met FDA. Doel: rolling submission, omdat data van 200 vereiste patiënten MANTA + MANTA RAy nog niet gehaald is per die datum. Bij succesvolle testicular tox data MANTA van deelpopulatie van zegge 100 patiënten, alsook bevestiging van (wederom) uitstekende veiligheidsprofiel FINCH 1 & FINCH 3 zal die rolling submission er gaan komen. Q3 NDA filing Filgotinib voor RA, liefst met PRV. Let's make it happen.CEO Gilead (wat een verademing deze man) We expect to have that meeting by midyear and we'll be looking forward to getting back to you on kind of the next steps. But we remain bullish on this and looking forward to bringing this as soon as possible to patients around the world and in the U.S.
Ter aanvulling nog deze quote van CEO op page 14 transcript cc.And so, I think I've been working with organization with the leadership team to really think about how can we accelerate some of the plans around filgotinib, how do we get ready for entering this very competitive space. And obviously with all of these launches comes both risks and opportunities, but I do think that we have a very good profile product on which to build one of our next legs successfully the whole leg of inflammation accordingly.
ze zijn in ieder geval door de bocht wat betreft AS. jammer dat er meer dan 1,5 jaar moet zitten tussen de uitslag van een fase2 en de opstart van een fase3. wellicht is de voor ons belangrijkste uitspraak uit de call gister: " But look I think it's important to us and Dan has brought this with his fresh eyes on the program recently is that there is some degree of urgency for us to get this drug approved as quickly as we can and obviously in collaboration with the regulators across the world." (John McHutchison) Er lijkt een nieuwe wind te waaien op GILD hoofdkantoor. De woorden zijn mooi, we wachten op de daden.
Nog iets opvallends in de governance van Gilead. Kite Pharma wordt niet geïntegreerd in de Gilead-organisatie, maar rapporteert als zelfstandige business unit aan CEO Daniel O'Day.
Dat is mij ook opgevallen. Voorstelbaar is dat op deze wijze voldaan kan worden aan het verminderen van de zorg die Onno heeft inzake het verdwijnen van de innovativiteit van GLPG bij overname en integratie in GILD. Als zelfstandige dochter onderneming van GILD valt mogelijk dit bezwaar weg bij Onno. Waarmee een overname van GLPG door GILD wellicht zijn instemming kan hebben. De, na het "vorkje prikken" met de nieuwe CEO van Gild, licht veranderde bewoordingen die Onno gebruikte bij bespreking van dit onderwerp wijst misschien in die richting.
Paar korte remarks nav @Rekyus 30-4-19. Ad2. Je kunt het ook omdraaien. Europese patiënten met RA krijgen de kans om in Manta-Ray Filgo te slikken voordat het op de markt is. Dit geldt natuurlijk ook voor de overige 3 indicaties, maar daar zijn natuurlijk nog geen overtuigende fase3 gegevens van bekend om dit als een kans ipv een belasting te zien. Ad3. Persoonlijk vond ik Walid anders aardig op de speculatieve tour zitten. Los daarvan Gala ligt gewoon aan de ketting van Gilead mbt communicatie rondom Filgo. Ad3. Gezien de distributie en leeftijd van mannelijke patiënten over RA en IBD zou het naast de keuze voor een fase4 ook wellicht een optie zijn om Manta vast te hangen aan IBD (lees UC) goedkeuring. Wordt er een jaar gewonnen en niemand loses face. Ad5. Men heeft aangegeven om met meer data op Eular te komen. Wellicht dat er dan kwantitatieve zekerheden worden gepubliceerd. Late breakers mochten tussen 5 en 15 april nog ingediend worden. Ad8. De verklaring op de Ava was wederom dat Vertex de lat wel erg hoog gelegd had. Te hoog om nog met een redelijke kans op een redelijk marktaandeel weg te komen. Mijn persoonlijke interpretatie is dat de samenwerking met Abbvie zodanig veel en vaak negatieve energie veroorzaakte dat de geslonken marktopportuniteit in combinatie met de opkomst van het Toledo onderzoek tot een strategische heroverweging heeft geleid. (zie ad7 en jou aap uit de mouw). Cheers.
Alvast van mijnentwege nog maar eens mijn dank en appreciatie aan de inhoudelijke posters (mouwfrotter is my second name, haha) Wat ik me gisterenavond afvroeg : Hoe zit dat nu eigenlijk met de komende milestones ? Is dat bij goedkeuring van filgo in RA in Europa ? in de States ? Is dat bij verkoop van het eerste pilletje "ergens" ? Zijn er ook milestones voorzien voor de andere ziekteindicaties, bij succesvol afleggen van een Phase 2 of begin van een Phase 3 ? Is er iemand die daar zijn licht op kan werpen ? Ik weet zelf eigenlijk niet zo goed waar die info op te snorren zou zijn. Dank bij voorbaat.
seekingalpha.com/article/4259526-oday... Getting filgotinib in gear O'Day waxed rhapsodic about this JAK inhibitor, which has completed three Phase 3 studies for rheumatoid arthritis, with other autoimmune disease indications being studied. He is not taking the male fertility issue - a question raised by an animal study or studies - lying down. He is insisting that an EU filing be done ASAP, i.e. in H2 this year. As far as the FDA, the company will meet with the FDA ASAP as well to discuss next steps. I would expect that the CEO will want to be present for this meeting. GILD will argue that filgotinib may be best in its class, and that most cases of RA are in women; and that in men, many are beyond child-bearing age anyway. O'Day made it clear that time is of the essence in launching this important product for RA. I interpret the new sheriff in town as implicitly criticizing the prior leadership (including Dr. McHutchison?) for being insufficiently aggressive on a key product launch. The times are changing at GILD. Under O'Day's leadership at Roche, the company has led the industry in Breakthrough Designation Therapies from the FDA. This only happens by understanding the science and pushing a drug that exemplifies the scientific insight rapidly through development so that the drug is actually a breakthrough rather than a me-too.
Toert schreef op 3 mei 2019 12:27 :
Is dat bij verkoop van het eerste pilletje "ergens" ?
Het staat allemaal "ergens"... eerste pilletje zal beschikbaar komen in de Benelux, volgens de voorspellingen van "Onno". Alles teruglezen dan maar.
If things break right, it's possible that GILD's market cap around $84 B could be accounted for by the present value of its marketed and pipeline HIV franchise. It's also possible that Kite will fly high: it's a high-risk proposition, but O'Day oversaw one of the world's largest and most successful oncology portfolios at Roche. Thus I expect a strong CEO choice for Kite, so the investment community may get more optimistic about its longer term prospects. Filgotinib should make a lot of money for GILD , and who knows if the remaining drug combo for NASH may pan out?
Rekyus schreef op 3 mei 2019 11:04 :
Nog iets opvallends in de governance van Gilead. Kite Pharma wordt niet geïntegreerd in de Gilead-organisatie, maar rapporteert als zelfstandige business unit aan CEO Daniel O'Day.
‘De zelfstandigheid respecteren’ ...
holenbeer schreef op 4 mei 2019 00:46 :
[...]
‘De zelfstandigheid respecteren’ ...
Dat zou voor Galapagos dus ook kunnen, met Vd Stolpe nog altijd aan het roer van de R&D machine "Galapagos"..
Pl4 schreef op 4 mei 2019 10:05 :
[...]
Dat zou voor Galapagos dus ook kunnen, met Vd Stolpe nog altijd aan het roer van de R&D machine "Galapagos"..
dit is een hint van O'Day richting Onno
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