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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
Is MRNA revealing major upside opportunity? BULL or BEAR? Today we're looking at MRNA aka Moderna, the darling biotech that might be the savior of us all should they produce an mRNA vaccine that could be more easily produced and distributed at scale than a traditional vaccine candidate. Reading into this story I've been intrigued, especially with the nice patterns forming in this chart with an easy to identify Impulse wave and a correction pattern currently forming. Unfortunately, this is always the riskier proposition and we must consider our Bull and Bear cases objectively so that we have a plan. As you'll see, we recently bounced off the 0.5 fib retracement from the all-time high of $95 all the way back to $53. Looks like a healthy bounce off that level. But we should almost always expect it. There is nothing to get excited about until we see a more convincing bounce with volume. While I love the long term pattern being set up in this chart with that hopeful bull target of $136.99, there's a lot of work to make up and resistance to overcome before we get anywhere close. The declining volume is something to watch out for. If you zoom in you'll see the upward channel off the bounce paired with the declining volume. This would indicate that short term we'll retest the low, and if we're lucky we can get a buying opportunity off that low and off the 0.618 at $43.50. Set your ladders appropriately and always calculate your stop loss according to risk preference fo % loss below average calculated cost. If you plan your buy levels and amount in advance you can easily calculate the average buy price and then subtract 20% for example to reach a reasonable stop loss which shields you from setting a stop loss too high and missing the following run, or setting it too low and losing more than you are willing to. Meanwhile, looking at the long term trend, we'll have some trading potential on the stock, but need to look for some volatility within the current correction pattern. Given the sharp increase and resulting decrease, one can assume we might see similar moves again in the future, though there's nothing to indicate exactly when at the moment until we see a better channel or a convincing wedge reveal itself. The longer-term trend bodes well for your everyday investor who's willing to take some loss for a very large potential gain. Should Moderna create their mRNA based vaccine in time and be successful with distribution, the value of this company would quickly skyrocket. I'm willing to bet on an optimistic future and I'm definitely keeping an eye on this opportunity with the buy ladders I've mentioned indicated. What's your Bull and Bear case on Moderna? How would you play this in the short and long term?
NASDAQ:MRNA
by Shadowfigure
2
$ABT Cup and Handle Pattern Formation on DailySentiment: Bullish Reasons: Technical Analysis & News Catalyst News has just been released that $ABT has been approved by the U.S to begin working on a 5$ rapid COVID-19 antigen test. I find this to be huge considering the inconvenience in searching for a COVID testing facility in certain places in the U.S as well as the discomfort associated with the actual process. In addition price action is just nice if Im being honest. It has underwent a long series of consolidation and converging trendlines and is due for a breakout.
NYSE:ABTLong
by DannyNoburu
Hold your breath peopleIf you have viewed my posts about IBIO , you would have witness the long term yellow line cutting through the 1.6-1.8 price point. Either this drop is to retest the long term channel or ... well... good luck to those that still believe in the company. I like the innovative company and the CEO's track record and was invested since $0.3. I really appreciate the person that referred me to IBIO on yahoo chatroom in Feb. I have started to trimmed my position when this started to breaking through all the support level like a hot knife through butter below the $3 dollar range. Wish the bulls good luck! just need one proper PR and this beast will rocket. stay safe! Side thought: I have seen in many chatroom and witness many high PT for all different kind of ticker (i guess you reading this have as well). Especially, 'this company has XXX product and it deserve XXX price' ,' this company will save the world '. I mean i am sure that biotech companies have all the smartest people in the world and they deserve tremendous net worth for all they have done for humanity, but unfortunately, this is a money society.Invest safe and wise people. Companies pulling moves like Novavax and Overstock are rare; i believe it is more luck than any other reason.
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by jordanadriano
4