RE:Regarding the transcript…lots of good & great stuffFrom the beginning, the future share price has always depended upon safety and efficacy. The company has a long history of safety data from animal studies as well as intra-tumoral and IV delivery. To deliver on the promise of clinical efficacy, the BRACELET results have to complement IND213. This provides the foundation for a true registration trial in ER+ mBC. Having two controlled trials with clinically relevant endpoints provides the substrate data to negotiate a lean, focused Ph III with a dramatically reduced chance of failure. Collating these data allows for the company and the FDA to agree on a trial structure with fewer patients and a boatload of surrogate and clinical markers of treatment effect. The trial would likely incorporate serial ctDNA analysis which has emerged as a real-time option for estimating treatment effect, overall prognosis and a predictive metric of future treatment needs. Importantly, the quantitation of ctDNA is predictive of patients that sustain deep responses vs patients who continue with significant tumor burden. Not a perfect test for all participants and still lots of work to do, but is increasingly being used in modern trials evaluating clinical effect in many different types of advanced cancer.
If the BRACELET results are unambigously positive, the negotiations for a Biotech/Pharma partner will accelerate and broaden. As most know, these negotiations take about as long as a pregnancy.....but this can be a human pregnancy or an elephant pregnancy!! Some of the hard work has already been done but, if the results are stellar, the company will re-negotiate from a position of strength and there will be more than one suitor.
ASCO's choice for a platform presentation of the BRACELET numbers (and the process to get there) is a significant positive. We all wait with bated breath to see the details of the updated dataset. These data could be transformative to the company's future and the share price trajectory. As always, the devil is in the details.
cheers, Geneman