Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-122

As another poster has already commented…Lonza Singapore Tuas , has already passed the last 20 site inspections successfully. I believe I read that the Singapore facility has never failed an FDA inspection !

https://www.lonza.com/about-us/our-locations/tuas-singapore

I have also heard it is almost unheard of for a therapy where a manufacturing inspection is undertaken to not be approved. I am not aware, that even the Walkersville problems of early 2017 led to any BLA rejections. I understand that even the delay referenced by Fiecepharma in the extremely rare, Liso-cel BMS example, amounted to about six months only, as it was granted FDA approval on the 2nd May 2021. Talk about clutching at straws. The only other occasion where I can find any real issues with a Lonza plant, dates is back to 2011, where production was subsequently moved from Hopkinton plant in Massachusetts to Visp Switzerland. The latter plant has a stellar safety record.

To show how certain posters are now clutching at straws, I reference the 33 successful inspections undertaken in 2021



https://www.lonza.com/annualreport/2021/documents/Lonza_2021_Sustainability_Report.pdf

Page 20 of the 2021 Sustainability Report
“In 2021 our sites underwent 33 regulatory inspections. In line with the increase of the commercial and development production, and a growing portfolio, the number of customer audits (on-site plus remote audits) also continues to increase. The successful inspections and audits are a valuable feedback loop to assure compliance across the company”

So after two successful mock internal and external audits of their Lonza Singapore facilty last year, Mesoblast must be feeling cock a hoop at the confirmation of the FDA site visit , which appears to be one of the last important milestone to be completed prior to an approval decision.


In my opinion, the application is 95% likely to succeed now….that is up from my previous expectation…and only a little higher than the William Blair analyst who has opined on the COS in his recent note !

Great news folks. Let’s wait to get past the Day 74 letter for the penny to drop this looks a winner. The institutions are being served up this opportunity on a plate. In my view today’s announcement substantially derisks the successful approval of this therapy. The shorters are trying to knock the price down to increase dilution and buy their stock back in a capital raising. What else can they do ? They have been successful so far in their manipulation of the stock price. History has shown, however, that most share prices run up materially ahead of a successful BLA application…with the current short position at 6%..they may have limited stock lending available to them….without a imminent capital raise they look terribly exposed…but they will not doubt defend their position. If one decent size long fund starts a holding in this Company , the shorters should be toast ! OP




Please do not rely on the accuracy of any facts or opinions expressed in the post above when making a financial decision .