Biotek-snakken

	30/12 17:51 af Joakim Von And	Uha,, så skulle jeg have købt dem til aktiesparekontoen idag ,,, men har dem heldigvis også i den frie beholdning
	30/12 17:41 af Fandel	Så bliver der købt ind. Dejligt....
	30/12 17:36 af Fandel	Bioporto får CE-godkendt NGALds i EU og tester corona-hurtigtest - RIT
	30/12 16:50 af 2311leeds	Langt
	30/12 16:19 af 2311leeds	Orphazyme blev desværre ingen nytårsraket som vi håbede på...Lagt fra kurs 125...Vi må håbe på 2021....Godt nytår
	30/12 14:06 af SwingSun	smed mine hansa idag. Den ligger noget underdrejet, med ret lange udsigter synes jeg. Er der nogen gode triggers i en nær fremtid?
	30/12 10:37 af Svingtraderen	helt enig og tak - udover teknisk svag måske noget skatteteknisk salg ultimo?
	30/12 10:03 af Svingtraderen	to complete its review of the hepatic, renal and QTc data that it requested and has begun discussions with the company on the labeling and safety data, with no issues raised so far, BofA said • The drug has a supportive efficacy and safety profile in a disease with limited treatment options: BofA • BofA recommendation maintained at buy, with price target $13
	30/12 10:02 af Svingtraderen	fra 28/12 - havde ikke set den: Orphazyme Buy Reiterated at BofA as FDA Review Extension Was Expected (PLX AI) – Orphazyme three-months extension on FDA's review of arimoclomol was expected and not a reason to change a buy recommendation, Bank of America analysts said. • Orphazyme said yesterday the FDA extended the review period of the New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC) by three months June 17 • FDA needs additional time
	29/12 22:55 af bb+	Synes generelt at US biotek er rødt i dag :-(
	29/12 18:04 af BioShare	Tak for info MM - giver god mening.
	29/12 18:02 af BioShare	Øv, det var dog et trist udsalg på Spero og Entasis :-( Det må være noget med en årsgevinst som skal trimmes...
	29/12 17:48 af Makingmoney	market because someone is using it off-label or in the wrong patients. Hope this helps clarify our launch strategy Best Klaus
	29/12 17:48 af Makingmoney	al on phase 2 data, we need to conduct a post approval study in parallel in the absent of a full phase 3 study. Lastly, the thinking behind this is also that clinics and clinicians will be monitored very closely so we ensure that the product is used according to protocol and the first clinics gain positive experience and follow-up data. It is critical for the long term success of our technology that is being used as intended so we don’t risk the product potentially being withdrawn from the m
	29/12 17:47 af Makingmoney	leading transplantation centers initially in countries with early patient access and reimbursement is possible. Also, since imlifidase is a paradigm shift in transplantation and probably the most innovative drug in this areas for the last 20-30 years we need to navigate local legislative systems and allocation systems. So don’t expect a large roll out like a traditional launch process also because we got approv
	29/12 17:46 af Makingmoney	Hansa Jeg spurgte primo dec om de ville komme med IR når de har doseret første patient her i EU. Herunder svar: We are preparing the launch activities in select countries as we speak and expect to communicate around the launch as indicated in our milestones. This is typically how healthcare companies communicate rather than first commercial sale (accounting related) or first dosing (more study related). As we have communicated it will be a very targeted launch focusing on a few but leading trans
	29/12 17:19 af lexus	jeg har selv hansa ambu orph og qfuel
	29/12 17:17 af lexus	optimistus hvad tror du selv på 2021
	29/12 16:46 af lexus	ja men kan der blive ved med at være krudt genmab
	29/12 16:37 af lexus	hold kæft det går godt .efter det var sendt
	29/12 16:36 af lexus	ja jeg så det efter det avr sendt
	29/12 16:13 af Optimistus	@Lexus- de skriver chf 287. Sikkert en fejl, det skulle nok være Skr. 287. Men ret interresant at RBC (Royal Bank of Canada) både har Hansa og Genmab i deres biotek toppick for 2021.
	29/12 14:14 af lexus	der står prismål chf 247.kan det mån passe1966kr
	29/12 14:02 af lexus	udrulling i europa i de kommende mdr.og forventer godkendelse i usa 2024

	29/12 13:59 af lexus	kik på placera under hansa der et link til15 bedste biotek 2021 incl hansa
	29/12 13:35 af koden	Hvornår kommer HANSA med nyt. Den er vist gået i dvale rent kursmæssigt
	29/12 13:00 af Svingtraderen	Velbekomme
	29/12 11:36 af Svingtraderen	velbekomme
	29/12 11:34 af rolling	også tak herfra
	29/12 10:52 af Svingtraderen	velbekomme
	29/12 10:52 af Fandel	Tak Svingtraderen.
	29/12 10:48 af Svingtraderen	Orphazyme: Nedenfor den slags "colour" som jeg efterspurgte - Redeye sendte buy ud i sidste uge.
	29/12 10:47 af Svingtraderen	Orphazyme: Our View to the Regulatory Update in NPCRedeye Research Note 2020/12/28 Redeye reiterates its probability rate for arimoclomol in NPC. While the extended NDA review, from previously March 17, 2021, updated to June 17, 2021, is initially disappointing, we also note that all outstanding information has now been submitted to the FDA. We consequently see a small risk for additional delays.
	29/12 10:46 af Svingtraderen	Background The FDA has extended the NDA review period for arimoclomol in Niemann-Pick Disease (NPC) with a standard 90 days extension. The NDA remains under Priority Review, and the extension does not impact the eligibility for a potential Priority Review Voucher (PRV). The updated PDUFA date is set to June 17, 2021, extended from previously March 17, 2021.
	29/12 10:46 af Svingtraderen	Our View We had looked forward to March 17, and believe we share the initial disappointment with the management team and investors on this delay. In the press release, we learn that Orphazyme has “responded to all FDA information requests and submitted all outstanding information regarding the arimoclomol NDA for NPC.” It also encompasses the crucial QTc clinical data. Thus, we see a small risk for additional delays. Based on the arguments below, we even believe that a potential decision by the
	29/12 10:46 af Svingtraderen	It is important to stress that the NDA remains under priority reviewAlso, we want to highlight the urgent medical need in NPCThe FDA does not plan to hold an advisory committee with expert panelists Naturally, other factors speak against an earlier approval. It attributes not least to the ongoing pandemic that complicates, for instance, site visits. Further, we cannot rule out that additional factors come up during the extensive NDA review, which could impact the timeline.
	29/12 10:46 af Svingtraderen	Impact on Valuation Orphazyme is a relatively small biopharma company, with not unlimited resources and we also see a risk that the US delay impacts the timeline for the EMA process. Hence, we don’t factor in any sales in the next year in Europe (a minor adjustment). For the US market, we factor in slightly lower sales for the coming years. The estimate changes fall under our margin of safety in our valuation, and we reiterate our Base Case of DKK 145 per share.
	29/12 10:45 af Svingtraderen	When delays occur, it is relevant to emphasize exclusivity protection. Arimoclomol in NPC has Orphan Drug Designation. From approval, it entitles to seven years of market exclusivity in the US and ten years of market exclusivity in the EU. Orphazyme also has a method of use patent for arimoclomol in NPC that expires in 2029, with a potential extension to 2032 (US) and 2034 (EU).
	29/12 10:45 af Svingtraderen	It is no surprise that the market trades the stock down on today’s news, currently in the range – 5-10%. Delays and uncertainties do seldom appeal to investors. Based on what we know today, our stance is that this news is about FDA needs sufficient time to review the NDA and that a decision will come on June 17 at the latest.
	29/12 08:23 af Fandel	God morgen...
	28/12 16:23 af BioShare	Lynn lyder næsten som en computer. Lader til at Sumi så "beholder" Asien. Men jo ret genialt at pushe produkter igennem Pfizers salgskanaler...super synergier og fantastisk motor. CFO melder at det ikke ændrer noget i relation til Sumi :-)
	28/12 15:04 af BioShare	Men kun hvis man kan stave til antibiotics...sorry for dysleksi, når det går stærkt :-)
	28/12 14:49 af BioShare	Spero - ligger til super stigning igen i pre market +11%. Ingen nyheder....måske antiboitcs alligevel er ved at blive lidt mere interessant ;-)
	28/12 14:48 af bb+	Godt spørgmål vedr. BO på MYOV. Jeg tror ikke på BO, når PFE har indgået en aftale vedr PC og UF som forhåbentligt bliver godkendt 1. juni 2021. Da Sumi ejer over 50 % af aktierne i MYOV, så tænker jeg, at de har godkendt denne deal.
	28/12 14:35 af lahn1	Sumi må have godkendt denne aftale, vel ? er BO aflyst eller er der nu blot to til at byde op ?
	28/12 14:34 af lahn1	jepp godt man ike solgte på nyheden.
	28/12 14:33 af bb+	Super med MYOV - godt man ikke solgte ved PC godkendelsen forleden :) de får 650m upfront - det er 1/3 af selskabets MCAP...
	28/12 14:33 af lahn1	Ha ha :D kunne ikke finde på at presse nogen ;-)
	28/12 14:33 af BioShare	Gad vide hvad Sumitomo siger til det!?
	28/12 14:32 af Sukkeralf	Flot aftale