It was very tight to get all my questions answered in 30 minutes, but I tried to get as much clarity as I could, let’s get straight to the questions and answers. Q: Why did you decide to expand the 103 study from 11 to 20 patients? A: To adjust the 4-5 & 6-7 years […]
March 22nd Biotech Update
A more rigorous FDA. Rising interest rates. Rising COVID cases in the EU. Lack of M&A. A lot of clinical trial failures. These are the list (probably not comprehensive) of the risks that have been used to explain the selloff in the sector. None of these have gone away and yet we still have the […]
March 11th Biotech (and Energy) Update
I think we are clearly in what sort of looks like a bottoming process but one that seems like it will be quite messy. The sector continues to be unable to generate consistently strong days but at least yesterday ended up not being a disaster. While continuation would have been great, it did not breakdown […]
March 10th Biotech Update
We obviously got a nice rebound but I would not signal the all clear yet. We have seen dead cat bounces during this pullback. I will grant that this feels different in that we rallied really strong on a day that there was negative news (another FDA CRL) and rallying on the back of bad […]
March 5th Biotech (and Energy) Report
We are in an old fashion sell off. Have we reached blood in the street/panic bottom yet? It does not quite feel like that yet but we are so oversold we could have that bounce today. If not then we are likely looking for a Tuesday reversal as markets generally do not bottom on Fridays. […]
February 8th Biotech (and MLP) Update
We have moved past the large cap portion of the earnings with positive price action in the sector but less so in the companies that are reporting. I do not believe that is related to the quality of the earnings as they were generally fine but more of a broader disconnect between large and SMID […]
Cardiol Therapeutics – Pharmaceutical-Grade CBD Entry to the Commercial Market in Canada: The Revaluation is Coming
Cardiol Therapeutics (CRTPF) is a Canadian company trading on the Toronto Stock Exchange (the “TSX”) since December 2018 under the symbol CRDL and on the OTCQX under the symbol CRTPF. Cardiol is focused on producing pharmaceutical-grade cannabidiol (CBD) products and developing innovative therapies for heart diseases, targeting acute myocarditis and other causes of heart failure. […]
APLIF – Appili Therapeutics and Avigan, the Antiviral Pill to treat Coronavirus: The Clinical Strategy for EUA
Canada TSX: APLI, US OTCQX: APLIF We previously reported on the need for COVID-19 therapeutics, including in the post-vaccine world, Appili Therapeutics and Avigan the Antiviral Pill to Treat Coronavirus (link here). Since the publication of that report, daily infections have only continued to rise, and nursing facilities and hospitals are facing an intensified crisis. […]
APLIF – Appili Therapeutics and Avigan the Antiviral Pill to Treat Coronavirus
Canada TSX: APLI, US OTC: APLIF Recent vaccine news from Pfizer (PFE) and Moderna (MRNA) provide some optimism to a world suffering from disease, death, and lockdown, and desperately looking for a solution to the COVID-19 pandemic for a return to normal life and work. Safe and effective vaccines will help contain the spread of […]
Pluristem- Expectation Ahead of CLI Phase-3 Interim Results
These are the questions that many are asking me these days regarding PSTI: * When will the interim Ph3 data be released? * What is taking them so long? * Is there a chance they are withholding the data because it is negative, and they will wait until full study data is available to provide […]
SRPT – The Street Will Get It – Study-103 Is the Fast Path to Full Approval
Last week, Sarepta Therapeutics ( SRPT) on the 3Q earnings call provided key updates on SRP-9001 gene therapy in Duchenne Muscular Dystrophy (DMD). Where they already met the FDA and resolved the FDA’s requests with regard to the potency assays for the commercial material to be used in the next studies, and they came with […]
Perimeter, OTIS – Optical Coherence Tomography and the Future of AI in Surgical Breast Cancer Treatment
Perimeter Medical Imaging AI (PINK.v) is a Toronto-based company with U.S. headquarters in Dallas, Texas developing advanced imaging tools that allow surgeons, radiologists, and pathologists to visualize microscopic tissue structures during cancer excision surgery. Perimeter has an innovative FDA 510(k) approved medical device, soon to launch commercially, that is ready to disrupt breast cancer surgery […]
October 15th Biotech (and MLP) Update
Not much to add as we gear up for earnings season and the sector basically following the broader market in its moves. It looks like we are switching from setting the new higher high level to establishing the higher low level. In other words, we are likely in the part of the uptrend where the […]
October 12 Biotech Update
We are not starting the week with new M&A but we are starting the week with strong momentum both with the sector and the broader market. Of course, very strong broader markets have not necessarily been great in recent weeks for the sector but there is certainly a chance that we break to new highs. […]
SRPT to Release 2-Years DMD and LGMD-2E GT Data at WMS-2020
It was a surprising and unexpected decision by Sarepta to release the long term data from the first clinical trial of DMD Gene-Therapy, a 2-years data to be presented at the World Muscle Society WMS25 Virtual Congress, despite the previous statements saying, we do not want to release data from an open label study while […]
September 24th Biotech Update
We are not quite in trouble with the sector despite the recent sell off and pain. Obviously the broader market is not helping but we have not broken below recent lows and still can reverse (needs to be soon) higher and make a higher high to start a new trend. Of course, nothing is guaranteed […]
September 14th Biotech Update
We are back baby! This is the M&A that the sector has been wanting. If this cannot break the sector out of the downtrend and push it back to highs (if not higher) then not much else could. The ideal scenario would be a push above the recent lower high today but we were pretty […]
Sarepta (SRPT) LGMD2E Data Readout and The Street Expectations
Sarepta will finally reveal the high dose LGMD2E data from the gene therapy SRP-9003 on Monday morning and put this highly underappreciated program on the big podium. In a surprising Friday post-market closing press release, Sarepta announced that on Monday, June 8, 2020 at 8:30 am ET, it will host a webcast and conference call […]
Cardiol Therapeutics – Pharmaceutical Cannabidiol (CBD) Long-Term Value Creation Will Lead the Way to Acute Myocarditis Clinical Trial
Cardiol Therapeutics (CRTPF) is a Canadian company that completed its initial public offering (IPO) on the Toronto Stock Exchange (the “TSX”) back in December 2018 and trades mainly on the TSX under the symbol CRDL while in the U.S. it trades on the OTCQX under the symbol CRTPF. Cardiol is focused on producing pharmaceutical cannabidiol […]
CHFS – Can The COVID-19 Pandemic Become the Inflection Point?
A Reported Shortage of Dialysis Machines Puts a Focus on Aquadex. Aquadex Smartflow System is being used to remove excess fluid from patients being treated with fluid resuscitation as part of the treatment for COVID-19, and in some cases is helping to relieve the shortage of dialysis machines at a growing number of hospitals. A […]
