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MESO

MSB - Updated AnalysisI hope you find my analysis useful. From what I can see, price seems to be holding within the trend channel (bullish sign) The moving averages are beginning to cross, and as you can see in the past, when that occurred, price rose (bullish sign). Price needs to hold above the lower trend channel and break past the .786 fib to confirm bullish price action. Stock is very news sensitive, price may rise in anticipation of an announcement and come crashing down if the announcement is lackluster. Trade with caution, but from what I'm seeing, right now is a good time to either average in or enter the trade for a decent risk-vs-reward scenario. *Not financial advice* *Just my opinion* *All investing and trading involves risk*
ASX:MSBLong
by TheTraderAndy
MESO, Triangle Descending (bearish)I found this pattern at tickeron website with the following data: STATUS = Confirmed CURRENT CONFIDENCE = 71% TARGET (EXIT) PRICE = 11.21 USD BREAKOUT (ENTRY) PRICE = 11.94 USD DISTANCE TO TARGET PRICE = 6.57% EMERGED ON = Oct 12, 08:00 AM (EDT) CONFIRMED ON = Oct 12, 11:59 AM (EDT) WITH CONFIDENCE LEVEL = 85% The Descending Triangle pattern has a horizontal bottom (1, 3, 5) which represents the support level, and a down­-sloping top line (2, 4). The breakout can be either up or down and the direction of the breakout determines which corresponding price level is the target. This pattern is commonly associated with directionless markets since the contraction (narrowing) of the market range signals that neither bulls nor bears are in control. When the price of a security consolidates in a somewhat volatile fashion, it may indicate growing investor concern that the price is set to break out. Trade idea If the price breaks out from the bottom pattern boundary, day traders and swing traders should trade with the DOWN trend. Consider selling the security short or buying a put option at the downward breakout price level. To identify an exit, compute the target price, by subtracting the pattern height from the breakout point. For downward breakouts the breakout level is the bottom horizontal line (1, 3, 5). Pattern height is the difference between the level of the bottom horizontal line and the highest high. To limit potential loss when price suddenly goes in the wrong direction, consider placing a stop order to buy back a short position or sell a put option at or above the breakout price.
NASDAQ:MESOShort
by AlTorress
MESOBLAST (MSB) - FDA will likely approve Ryoncil (analysis)MSB is developing Ryoncil - an IV stem cell therapy for the treatment of acute graft versus host disease (aGVHD) in paediatrics. aGCHD is a potentially life threatening (up to 70-90% mortality) complication of bone marrow transplants (indicated for leukemia/lymphoma etc). Ryoncil has been accepted by the FDA for priority review with a PDUFA action date of US 30th September (1st Oct in AUS). Why might the FDA approve Ryoncil? Probability wise: - Oncology therapy's have an average 88% probability of being approved once they have been accepted for review (data averaged from results from Wong et al (2018), Thomas et al (2016), Hay et al (2014), and DiMasi et al (2010)). - As part of the review, the FDA requested a recommendation from the Oncologist Drugs Advisory Committee (clinical oncology academics and statisticians) who on Aug 13th voted 9:1 that the available data supports the efficacy of Ryoncil. - Ryoncil has been approved in Japan for the last 5 years with strong yoy growth. Benefit-risk ethics analysis: - There are no FDA approved treatments for aGCHD in pediatrics and no therapies are considered standard of care. - Ryoncil is effective vs placebo (28d survival 64% vs 38%, 100d survival 79% vs 54%). - Adverse Effects of Ryoncil were not statistically different from placebo. In fact unapproved treatments (steroids) carry high risk of toxicity. - aGCHD has a 70-90% mortality rate, there are no FDA approved treatments, Ryoncil appears to be effective, risk of doing harm by approving Ryoncil is low. It seems like the ethical decision is to approve Ryoncil. Why might not the FDA approve Ryoncil? - The FDA prefers double-blinded, placebo-controlled RCT's to show effectiveness. However, due to the high mortality rate of aGCHD, enrolling children into an RCT is clearly not ethical. I'd argue that the single arm study comparing to an external control population is as good as you're gonna get. It also does not need to be blinded as the primary endpoint is mortality. The 9:1 ODAC vote seems to support this. - The study was small (N=14, N=13). It might be reasonable for the FDA to ask for another (potentially larger) study to replicate the results which is a risk. - Quality control concerns. The FDA raised concerns that the way MSB measure the potency of the Ryoncil (CQA's) may not be enough to ensure the clinical effectiveness of the product. I'm no expert in this part but when MSB responded to these concerns in the webcast, they kind of just reiterated the CQA's from their manufacturing were very high but didn't really address the concern that the CQA's might not translate to clinical effectiveness. It might be reasonable for the FDA to ask for more data on this. - Even if more data is requested, Ryoncil can still be provisionally approved. Conclusion: The FDA will likely approve or provisionally approve (with the request of more data) Ryoncil therapy for pediatric aGVHD in the US which will strongly improve the revenue potential of MSB.
ASX:MSBLong
by Sean_Kenworthy