What a week it’s been for Mesoblast shareholders. The week had a promising start with a healthy gain on Monday on optimism around the upcoming ODAC meeting which was to review MSB’s data supporting the BLA for its treatment for SR-aGVHD, RYONCIL. Late on Monday night/Tuesday morning, the FDA released a copy of the questions it wanted Mesoblast to discuss at the ODAC meeting and the market became spooked at the tone of the rigorous questions that were being asked. The questions appeared to indicate that another trial may be required and they also questioned how robust the data that formed the basis of the application. The final questions can be found here: https://www.fda.gov/media/141127/download https://www.fda.gov/media/141128/download Prior to the release of the FDA questions, the US Nasdaq had finished it’s Monday trading day and showed healthy gains. Upon the release of the questions, MESO fell around 20% in Nasdaq after-hours trading which implied a grim day ahead for Tuesday trade in Australia. The selloff in Australia was savage, with MSB finishing down around 30% for Tuesday, with hundreds of traders and unsophisticated investors panicked by the news. The ferocity of the fall prompted Mesoblast to release the following announcement to the ASX: http://investorsmedia.mesoblast.com/static-files/1b07c5ac-5844-4491-907e-e051cb43a214 In the announcement, MSB indicated that they had “extensively prepared for this meeting” and provided links to their briefing book. This announcement failed to placate the fear-based selling with MSB shares falling a further 8% on Wednesday’s trading, which, combined with Tuesday’s fall had mauled the share price. There was a small rebound in the price on Thursday, which was the final trading day in Australia before the meeting. On the night of the meeting, I decided not to stay up all night due to work commitments the next day but I did get up an hour early to login to the meeting. Whether it was my lousy NBN connection or something else, the audio feed of the meeting kept cutting out on me so I resorted to reading the live text feed, which was not ideal. During the feed of  I also tuned in to the HC thread about the meeting and was blown away by the number of posters who appeared to be doing an all-nighter tuning in and posting their thoughts. MSB shareholders may be many things but most of all they are passionate about this company.  Going by the HC posts, there appeared to be growing concern around the halfway mark of the meeting that MSB may get a negative vote from the committee members but many of the HC posters kept their sense of humor. It was great reading. At 6 am I had to head off to work, so I tuned out of the feed. By the time I got to work, I’d formed the opinion that maybe we had to brace ourselves that the ODAC would vote down MSB’s application. In order to keep my mind relatively on my job, I decided not to look at the results of the meeting at 7 am, instead, I figured I’d look at 10 am, just as the market was opening. The first thing I looked at was the MSB page on HC and thankfully the first thing I saw was a post indicating a positive vote at the meeting. What a relief ! Due to a busy day at work, I didn’t get to read too much on HC’s MSB threads, but even a cursory glance indicated the trolls, that love to upset MSB posters when the outlook is perceived as negative, had crawled back into their little holes.  Great to see. By the time I got home from work, Mesoblast had released an ASX announcement with the positive news regarding the tick of approval from the ODAC.  You can read the announcement here: http://investorsmedia.mesoblast.com/static-files/ff81b59d-d721-4b95-9cf6-baf6d3570f91 The final decision for approval rests with the US FDA, though with the result of the ODAC vote in mind, it appears almost certain Mesoblast will gain marketing approval. This is a significant achievement. MSB will become the first company to gain approval for an allogeneic stem cell treatment in the US market. Other companies have tried and failed along the way. Final approval will be a historic day not only for Mesoblast and it’s long-suffering shareholders, but most importantly, for the sufferers of the horrible GVHD, they have the most to gain from this new treatment. The response to the news on the ASX was immediate with the price for MSB shares shooting north, finishing the day 39% higher. Better yet, MESO ADRs trading on the US Nasdaq was up 51% indicating strong gains are likely in Australia when trade resumes on Monday. Happy days

Categories: Uncategorized

0 Comments

Leave a Reply

Avatar placeholder

Your email address will not be published. Required fields are marked *