Cell Therapy News/Articles, page-7019

hi
This was in the SMH this morning it mentions a couple of options for MSB. apologies if it was already posted.

cheers

10.35am
Mesoblast investors digest regulatory hurdle

By Emma Koehn
Mesoblast shares gained 2.2 per cent at the open but at $3.26 the company is still sitting 36 per cent below last Wednesday’s price, when shares were trading at $5.11 prior to a trading halt.
The stem cell treatment developer’s US listed shares were also whacked 36 per cent in Friday’s session on the New York stock exchange as the market digested the news that the FDA had demanded more evidence that its flagship product worked prior to approving it.

Bell Potter analyst Tanushree Jain said the FDA decision on mesoblast came as a major shock after an advisory committee for the regulator voted in favour of the product in August.
The company said it had requested a ‘Type A’ meeting with the regulator to discuss an accelerated path to approval after the FDA said it should conduct at least one other randomised study in adults and children to show its stem cell treatment Ryoncil works against graft versus host disease, a severe immune response after bone marrow transplant.
Bell Potter analyst Tanushree Jain said the FDA decision came as a major shock after an advisory committee for the regulator voted in favour of the product in August. Jain said in a note there were two possible outcomes moving forward.
One option would be that Mesoblast would be able to negotiate to speed up approval of the treatment for children only, provided another post-approval study was done in adults, which would mean the product would come to market with a three to six month delay.
The other option is that the regulator demands a full randomised trial to take place in adults before any approval is given, which could push approvals out another year but would mean the product could end up being green lit for kids and adults on the same date.
If the second option was to happen, “we then believe that Ryoncil may get approved for the US market for COVID-19 ARDS as potentially the first indication (subject to positive results from the ongoing 300 patient randomised, controlled trial).
GvHD then is likely to become the second indication expanding its label,” Jain suggests.
Mesoblast is currently testing Ryoncil for use in COVID-19 patients and is expecting to see data from its phase 3 study in the coming months.