MSB - a new dawn, page-2008

@JuliusCoolius

You have made your points. A careful mixture of impending doom combined with a caveat that it might just work. You made the same siren warnings regarding having to “pick up the pieces” in your post on the 5th December 2024 just in front of our historic approval . Luckily you don’t seem to have the same contacts as Phil Krause in the FDA ,despite living in the USA. Funny that . Such a small place.


This Administration actually managed to make made a nonpartisan appointment of Dr Marty Makary as FDA Commissioner. He secured support as a respected surgeon from both sides of the Senate . I have listened to several round table talks conducted under his leadership which are broadly supportive of cell and gene therapies. Other appointments such as RFK Junior as head of HHS are obviously more politicised on subjects such as abortions , vaccines, fluoride and drugs. which has kindled obvious concerns that gold standard science will be ignored . I am not aware that RFK has any interest is wanting to delay orphan drug approvals so I wait for you to offer more evidence. After all , your previous post you made recognises that with a fair wind the share price of Mesoblast could “be a 40 bagger” .. so no need to panic !
Nicole Verdun was a respected and trusted figure in the FDA. More importantly she was the established point of contact for Mesoblast and most cell and gene therapy companies. Her interim replacement has already been announced. Vijay Kumar is an experienced, long serving branch chief, from the OTP, so I am not expecting the wheels to fall off just yet… but you know best. Changes at the top of the FDA are like musical chairs after Presidential elections. The badgering of Jerome Powell, who has only one more year left as Chair of the Federal Reserve, has demeaned the high office and independence of monetary policy and is another example of Trump turning on his own choice of Chairman..so anything is possible under the guise of executive orders.. but they normally end up neutered by the justice system .
Meanwhile Makary has laid down some very sensible policies to speed up the processing of bla applications without necessarily diluting the scientific scrutiny. Whilst wishing to champion his own voucher system he has given specific reassurance that all existing fast track and accelerated approvals pathways would remain unchanged and function as previously . So where is your evidence ?

The evidence I want to rely on is the fact that Ryoncil is now an approved product whose clinical effectiveness puts Ruxolitinib to shame in severe grade GVHD patients and in terms of duration of response . To think that almost 45% of patients are Ruxolitinib Refractory is shocking. The Type B meeting notes for both Heart and adult sr aGVHD (in early August )will give us decisive guidance on our journey forward .
Oh , I almost forgot. The other evidence is hot off the press. The latest trading statement which appears to suggest we are doing very well against expectations.
So thanks for your hearty portion of honest critique. There are several challenges to overcome such as a US manufacturing base … but I think Mesoblast is very well placed to deal with them . I have to agree with you . Looks like a “40 bagger” at least to me . OP

Please do not rely on the facts or opinions expressed in the above post when making an investment decision .