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 […]
2021 Markets Outlook – Are We Ahead of A Major Correction?
Despite the fact that we are mainly focused on the biotech sector, we have to keep an open eye on the overall markets and the correlation with the geopolitics situation in the US. While the SP-500 index is on tear since the 666.79 points back in March 2009, reaching an All-Time-High of 3826.69 points last […]
Cardiol Therapeutics – Pharmaceutical-Grade CBD Entry to the Commercial Market in Canada and a US Phase 2/3 Covid Trial: 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 […]
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 […]
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 […]
A Closer Look at The SPX
S&P 500 Index SPX Last week we had a strong move in the overall markets, were the XBI had a long GREEN weekly candlestick closing at $83.43 just above the $82.38 resistance line. But today I’m gonna take a look at the SPX that lead the move and reflecting to the XBI as well. […]
Watching The XBI For The Next Move
SPDR S&P Biotech, NYSEARCA: XBI It is interesting to see the closing in the XBI today and tomorrow to get the final weekly candlestick. After the sharp decline along with all other sectors in the US markets, the XBI had reached the bottom of $62.94 on March 18, then the technical correction began, and […]
Follow Up the XBI and Preparing For The Next Move
Started following the XBI move lately as you remember at the forum, and as it is getting closer to the next move, I think it is a good idea to put all at one TA report. On January 9th: Continue following up the biotech sector closely, watching the XBI for a double top or reversal, […]
DMD Data by Giant Pharma Pfizer Kept Sarepta In the Driver Seat with Superior Drug
Pfizer (PFE) presented its first set of data (n=6) from the mini-dystrophin gene therapy for DMD (PF-06939926) at the PPMD conference on June 28th. Much speculations surrounded Pfizer’s decision to report the dystrophin quantification using mass-spec. Sarepta (SRPT) has used WB-western blot since 2015 during the Eteplirsen FDA approval process. Sarepta has also used it in […]
Sarepta – LGMD2E Data May Become the Next Inflection Point
Sarepta Therapeutics (SRPT) has a long history with several inflection points through the years. Moving upward from a penny stock back in the days they used to be called AVI Biopharma, through the first inflection point and stepping under the spotlight with first real eteplirsen success, meeting the primary endpoint of increase dystrophin and achieving […]
PSTI – The Future Regenerative Medicine Leader – Trading Under the Radar
• Regenerative medicine company with late-stage studies in 3 indications • Ready to use GMP-certified manufacturing facility for PLX cells • Aging is often associated with debilitating medical conditions, massive unmet needs • Over 617 million people in the world are over 65 years old • Over 70 million people in the U.S. are over […]
CEO Interview: Bellus Outlook Post the Positive Ph1 Chronic Cough Study
Back in August I published my deep dive report “Bellus – David vs. Goliath, Can BLU Deliver A Better Chronic Cough Drug Than Merck?” (Link) with a bull thesis stating that Bellus Health (TSX: BLU.TO) (OTC: BLUSF) have a good chance to pass the first true hurdle and achieve positive results from their clinical trial […]
Bellus – David vs. Goliath Round 2 – Can BLU Expand the Pipeline Following Merck Lead?
Back in August I published my first deep dive report “Bellus – David vs. Goliath Can BLU Deliver A Better Chronic Cough Drug Than Merck?” (Link) about Bellus Health (BLU.TO) (BLUSF) a biopharmaceutical development company based in Montreal, Canada. Its lead drug candidate is BLU-5937 which is a highly selective P2X3 antagonist that has the […]
