MSB to dispute FDA finding in Type A meeting, page-226

I must say that the FDA ‘s decision has been a surprise to both shareholders, the management of MSB and the medical fraternity involved in the clinical trials. To request for at least another randomized trial to provide effectiveness of remestemcel-L and to further require scientific rationale to demonstrate the relationship of potency measurements to the product’s biological activity is an absolute nonsense. Further as the product has been used in Japan over the last few years and there are no concerns on safety and efficacy reported, why is this not evidence enough for approval.

On 7 August 2020 the FDA approved Olinvyk an opioid for management of moderate to severe pain in adults where alternative treatments are inadequate. The FDA announced that addressing the opioid crisis remains a top priority for the FDA to reduce the number of Americans who are addicted to opioids. This shows how illogical the FDA is and to approve another opioid where there is an existing opioid crisis is imbecilic.

Many have been affected by the decision taken by the FDA especially when the ODAC voted 9-1 in favour and it was expected to get approval so that the product could be introduced in this calendar year.

Although MSB expects to meet with the FDA within 30 days, the fact remains that FDA may not budge and we will be another 3-4 months away from possible approval.

Based on this it is understandable for shareholders to voice their feelings and frustrations and fuel down-rampers and the others to post nonsensical comments. I have no time to read all the posts and from the handful I have read, it does pose a problem to some who bought in anticipation of big profits should the FDA’s decision been as expected. Those who bought at the $3-5 mark will now be looking at a loss in value and may even consider to sell off and move on based on their financial situation. It is now up to the individual to make such decisions based on their circumstances. Although my average price is in the mid $1 range, I am also affected and will have to give some thought of what needs to be done.

I am not sure what the interim results are for CHF and CBP, and not sure when these results will be made available, although we reckon it will be sometime this month. In the meantime the manipulators will be doing best what they do and we will see history repeating itself. How low the price will plummet to, is anyone’s guess and for those who intend to wear this storm, it is another setback and based on the current economic conditions which appears bleak, its’ going to be a long while before economic normality returns.

Mesoblast has adequate financial resources for at least another 7 quarters and further facilities for a bit longer and hence it is not in dire straits financially.

It would be interesting to see what pans out over the next few months and hopefully we will get the news we are all waiting for. This is my view and not advice.