It is disappointing that the queries raised by the ODAC has been...

It is disappointing that the queries raised by the ODAC has been used negatively to pull down the price of MSB and even the ABC is guilty of misinformation by attributing the fall in price as a result of the negative report by the FDA on its Covid -19 treatment. The manipulators capitalised on what were legitimate queries and exploited the situation and unfortunately many retail holders who bought at the high $3 or $4 marks panicked and dumped their holdings.

The draft questions by the ODAC are fair in my opinion and this gives MSB the opportunity to enlighten the panel and clear what doubts they have before voting.

The first two questions relate to Product Characterisation :1.Product Quality and Attributes to ensure that the key qualities are maintained consistently from lot to lot and the potency assay for Remestemcel-L. and 2.Product quality attributes that could be controlled better to assure consistent quality with regard to safety and effectiveness of the product. For 1. I do believe that MSB has dealt with this rather well by a detailed report on the manufacturing process, characteristics of the cells, the history of development, quality controls, manufacturing process, process improvements, storage and distribution controls and the fact that it has a product life of 4 years when stored in the prescribed manner, adequately would impress the panel. For 2. It is of a technical nature which is quite beyond me however the conclusion summarises the answer which any layman can understand which stresses that SR-aGVHD is a serious life threatening complication where there are no approved treatment and the current firstl-ine steroid therapy has the highest treatment failure and mortality rates and Remestemcel-L was developed to address the need for an effective treatment. The safety issue has demonstrated as being well tolerated compared to current available therapies. Therefore it has demonstrated efficacy and favourable safety profile and addresses unmet medical needs in SR-aGVHD patients especially in children under 12 years old.

The remaining two questions are in regard to the limitations of the single arm study design and its strengths and weaknesses and the last question dealt with the significance of two trials 265 and 280 and whether the results of such trials were relevant to the effectiveness of Remstemcel-L for treatment. It also poses a question about the possibility of an additional clinical trial to support effectiveness of the product and aspects of trial design which MSB may want to suggest to be incorporated in such a trial. Once again this is of a technical nature and for me to summarise, the knowledge and expertise of which I do not possess, would be disastrous. I would say that MSB has the opportunity to put a case which supports the use of Remstemcel-L and after years of product development, I am confident that they are the experts and should be well positioned to convince the panel to vote in favour of them.

We will have a verdict on Friday here and hopefully that would reverse the falls which we have had to put up yesterday, today and possibly tomorrow. This is my opinion and does not constitute any financial advice. I do encourage individuals to do their own research and not be dependant on what others may suggest.