IBB wave checkLooks like ABC pattern just wrapped up and another wave has already played out as well.
EW could be so complicated so we don't know what pattern will be going forward at this point.
The RSI bullish divergence was missed though. hats off to those who caught it.
Disclaimer, this is only for entertainment and education purposes and doesn't serve by any means as a buy or sell recommendation.
Personally I hold both long term long positions and occasionally short term short position, for disclosure purpose.
Biotech
Biotech etf catching up to the Qstested recently pitchfork upper line and bounced off..bullish sign.
depending on timeframe but for this one BBC is catching up to the Qs.
short term it looks just as over-exteneded as the Qs.
trading will get very choppy short term.
Disclaimer, this is only for entertainment and education purposes and doesn't serve by any means as a buy or sell recommendation.
Personally I hold both long term long positions and occasionally short term short position, for disclosure purpose.
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.
CLVS pitchfork playthe stock is still very volatile with a beta of about 1.4. Let's see if it can break the upper trend line first.
Disclaimer, this is only for entertainment and education purposes and doesn't serve by any means as a buy or sell recommendation.
CLVS big accumulation ongoing stillI published an idea about CLVS early on but since then the stock took a hit and I incurred some loss from the trade. However, by looking at the volume and OBV lately, you can tell that people are buying the stock in expectation for something big.
Disclaimer, this is only for entertainment and education purposes and doesn't serve by any means as a buy or sell recommendation.
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?
Photocure $PHO trading above previous top as shorts reduce posThe Photocure share price has been increasing steadily even in the face of short sellers thas has been adding to their positions in Photocure stock for three weeks straight.
With the stock now trading above the last top, longs will be hoping to see a short squeeze effect in the the price development.
Recent 50SMA / 200SMA golden cross.
Top 20 ownership increasing steadily.
CLVS could be a huge buy here RSI/MFI breakoutfinance.yahoo.com
Disclaimer, this is only for entertainment purpose and doesn't serve by any means as a buy or sell recommendation.
DXB - setting up nicely - BullishKey Technicals - flag/ascending triangle, entry on breakout.
Key Fundamentals - the Australian Government’s Medical Research Future Fund (MRFF) through the
Biomedical Translation Bridge (BTB) program is supporting development and clinical evaluation of
DMX-200 as a new treatment for respiratory complications as a result of COVID-19 in global clinical
study with a potential fast track pathway to clinical practice.