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Any thoughts on FDA approval (subject to manufacturing inspections), reviewing the results presentation the tone seemed quite bullish, slide 18 highlights -
"Commercial & Medical Affairs staff in place with plan to reach 84 by H2 2022 launch"
U.S. FDA – NDA Status
• Remaining clinical & manufacturing site inspections pending
• Mid- & late-cycle review meetings complete
• PDUFA is Apr 30, 2022 subject to FDA scheduling limitations
EMA – MAA Status
• Completed the 120-day assessment, & now entering the later
stages of MAA review
Yes I agree, very bullish, the only issue I can see is a delay to the PDUFA due to GMP inspection delays caused by the travel restrictions and rolling lockdowns in Shanghai. We could well get EMA approval before the FDA one. What is unclear to me is the split between U.S. and European revenues for Sulanda but that will become clear when we see the figures in the 2022 results. We can also expect an update shortly on who we will out-license to in Europe.
In terms of the science, Hcm has engaged with FDA about the volume of data needed and the bridging study design so it looks likely to be a positive clinical opinion….although they could ask for additional confirmatory studies.
I doubt there is a way round the inspection parts of the process so that will likely lead to delay with covid continuing To afflict China Hutchmed should be looking at contingency plans and contract manufacture in Us/Europe. However that will also need inspecting so there could be a sizeable delay. Although we know there is potential for delay the company needs to get the story out rather than spring a surprise on 30 April which is there style.
btw does anyone else find this site has slowed up and typing is painfully slow to appear
Thanks, I have no idea what's involved or how long the factory inspections take, if it was a day or so and not protracted staff may be able to get an exemption to travel.
My comment on the presentation in terms of a bullish tone relates to the upbeat nature but also (I think it was Christian) who mentioned 'two, billion dollar products' - need to listen to it over but pretty sure this was in response to Suru & Fruq analyst question.
Jatw, a while back LSE had some browser checking page load, seems to have gone now though.
CH did say the had hopes of having two billion dollar products, it was quite a surprise to hear him say that he is usually much more cautious....must have been demob happy.
The FDA have an office in China so one would assume they will use local inspectors rather than U.S. based ones so that should help. I would have thought most of the inspection is remotely carried out with details on the plant itself, material handling, quality control standards etc etc plus a physical verification.
For the EMA ecxisting certifacte holders have bene given an extension until Sept 2022. For new sites and facilities within and outside the EEA that have not been inspected or where an inspection is required, a remote inspection may be carried out. On-site inspections will resume as soon as feasible.
It is therefore quite likely that the EMA approval may occur before the FDA one.
Its nice to end the week on a bit of an upbeat note after such a crazy week.
JPMorgan look to have sold around half their holding at 29 HK dollars perhaps in response to their own bearish note
Pinched from another forum (posted 14th March):
"JP morgan describes Chinese internet stocks as being “uninventable” over next six months to a year.Has cut forecast on Alibaba to $65 which seems a bit late given its already fallen two thirds in the last 12 months.Other stocks have been downwardly revised ie JD.Com etc.Of course,this sort of recommendation keeps storm clouds firmly over all Chinese listed equities."
https://sc.hkexnews.hk/gb/di.hkex.com.hk/di/NSNoticePersonList.aspx?sa2=np&scpid1=15358&scpid3=0&scpid2=344192&sa1=pl&scsd=12%2f03%2f2021&sced=12%2f03%2f2022&pn=JPMorgan+Chase+%26+Co&src=MAIN&lang=EN&g_lang=en&
Less than 48 hours later news broke of China olive branch, Alibaba and other stocks had their biggest rally since 2008 crash.
What a banana skin ..
I think JPM have called this wrong, because it is in the interests of both U.S. and China Regulators to come to some form of agreement
It 's an even bigger banana skin if you factor in their short position of 8,348,005 shares, so not only have they sold around 100m GBP of stock they failed to close their short too.
Received quite a lengthy reply from SEC yesterday, if there is anything of interest will post once digested.
"Foxconn, a major Apple supplier, has “basically” resumed normal operations in Shenzhen, China after an uptick in Covid cases in the area caused it to pause production last week, according to Reuters."
https://www.cnbc.com/2022/03/21/apple-supplier-foxconn-resumes-normal-operations-after-covid-pause.html