I hope you like my analysis. Very risky stock to invest in, but with potentially big upside in the scenario that there is good news from the FDA in future, which could conclude with a 3-4month Phase 4 trial (CRL) and see the price action head towards 8.60$, after breaking through previous resistances and fib-levels on the way ... this is in order to respect the current trendline which formed (weak trend, given the large gap in the chart) since close Friday/open today.
My conservative analysis based on 2 fundamental outcomes would be the following:
From now til around March next year, if there are mostly low-impact news/announcements along the way, and no serious negative ones (impossible to predict), the stock will likely trend up from here, riding hype of a potentially large and favorable outcome from the FDA, as well as other potential catalysts.
I estimate based off my TA as well as FA that it may take up until Feb 21' to reach the previous high (5.70) - 0 on the fib. I estimate if that happens + good news comes out, 8.60 is not unreasonable of a target. Higher in future if they release positive outcomes for their other drugs in trials, if they are able to expand their applications for drugs in the pipeline, and nail distribution. This will lead to more profits, cash flow, and hopefully no debt on their balance sheet.
If FDA doesn't approve, then I am convinced the FDA is corrupt, only cares about national interests, or who bribes them the most. You have Opioids/fentanyl crisis in America because they're prescribed like candy, and where opioids are the most commonly prescribed for lower back pain -- another ailment MSB's product line can potentially treat.
RSI is currently oversold, based on the space between observable "cycles" in this stock, there's usually around 120-130 days between bull/bear trends (based off most recent 3). 120-130 days matches my thesis of march/april if all goes well. It could happen much sooner, much later, or not at all. But I think probability leans in favor of this outcome. Of course, nobody has a crystal ball.
*NOT FINANCIAL ADVICE, DYOR. ALL INVESTING CARRIES RISK OF LOSS OF CAPITAL. ONLY INVEST WHAT YOU CAN AFFORD TO LOSE. *
very strong analysis.
One only needs to look at Ruxolitinib to see the shady business of the FDA.
Ruxolitinib carries an extreme safety concern for patients, Novartis who only carried out a single arm study which showed a OR of 69% over the standard of care (30%) was approved by the FDA without a CRL on safety concerns.
Compared to Rynocil (MSBs product) which carries minimal to zero safety concerns (FDA recognizes this), has proven efficacy upwards of 80% compared to standard of care for srGVHD (10-40% depending on severity), MESOBLAST also has 3 studies to back Rynocil's use in srGVHD, given the overwhelming efficacy in all three studies (one being a control study in adults) the FDA still issued a CRL to gather more data in adults.
During the ODAC hearing (which had voted overwhelmingly in favour of Rynocil 9 to 1), Silviu Itescu stated a double blind placebo controlled study in adults for srGVHD will proceed post approval, however the current application of Rynocil's approval is only for paediatrics, carrying out a control study in paediatrics carries ethical issues (nobody wants to let kids die right?) however the FDA doesnt seem to care as its stated it would like an ADDITIONAL control study in kids and/or adults.
So in summary:
FDA recognizes zero safety issues
FDA recognizes efficacy over all other treatments in paediatrics
FDA recognizes three completed studies supporting Rynocil in srGVHD, along with MOA.
ODAC voted overwhelmingly in favour of Rynocil's use in srGVHD, 9 to 1.
The product is set up for approval as it checks all the boxes set out by the FDA, the only obstacle is the FDA.
Andy_D
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@Mikail-Morningstar, very good information and summary there. I'm not too familiar with all the science, but with the ODAC voting 9:1 and a CRL and not a flat out rejection, there's still a large chance this will get approval with more data, as well as all the other drugs in the pipeline which could really boost this companies reach and revenue over the years to come. Revolutionizing medicine will come at a very very high valuation in my opinion. *IF* these medicines get approved, it is not unreasonable that this company could reach 50bn some day.
rlndgulyas
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@Mikail-Morningstar, You addition and technical analysis for me definitely suggests that the stock is a buy at this point.
rlndgulyas
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Hi. Nice analysis. I got to the same conclusions. Today (16.10.2020) the stock hot rock bottom comparing to previous lows. It's a bit below the 200 D MA. I would consider this a good spot to buy. Looking at the chart there can be big gains made with a small loss(depending on the stop-loss you set), so Mesoblast is a pretty good asymmetric investments.
Uptrend will be defined my the following in my oppinion:
1. The Type A meeting with FDA will be announced till end of October. In case this doesn't happen we have to wait for......
2. Earning in 23.11.2020 and
3. Trial results of remestemcel-L around end of this year start of next year. Currently they have 50 patients recruited for their phase 3 trial and are expecting to have 100 by December.
I would suggest this stock to those who are patient and can take some volatility and uncertainty
One only needs to look at Ruxolitinib to see the shady business of the FDA.
Ruxolitinib carries an extreme safety concern for patients, Novartis who only carried out a single arm study which showed a OR of 69% over the standard of care (30%) was approved by the FDA without a CRL on safety concerns.
Compared to Rynocil (MSBs product) which carries minimal to zero safety concerns (FDA recognizes this), has proven efficacy upwards of 80% compared to standard of care for srGVHD (10-40% depending on severity), MESOBLAST also has 3 studies to back Rynocil's use in srGVHD, given the overwhelming efficacy in all three studies (one being a control study in adults) the FDA still issued a CRL to gather more data in adults.
During the ODAC hearing (which had voted overwhelmingly in favour of Rynocil 9 to 1), Silviu Itescu stated a double blind placebo controlled study in adults for srGVHD will proceed post approval, however the current application of Rynocil's approval is only for paediatrics, carrying out a control study in paediatrics carries ethical issues (nobody wants to let kids die right?) however the FDA doesnt seem to care as its stated it would like an ADDITIONAL control study in kids and/or adults.
So in summary:
FDA recognizes zero safety issues
FDA recognizes efficacy over all other treatments in paediatrics
FDA recognizes three completed studies supporting Rynocil in srGVHD, along with MOA.
ODAC voted overwhelmingly in favour of Rynocil's use in srGVHD, 9 to 1.
The product is set up for approval as it checks all the boxes set out by the FDA, the only obstacle is the FDA.