RE:RE:RE:RE:RE:RE:REALITY is the STOCK is DEAD untilAll great info, thx all.
Yes, fast track for Trodelvy Apr. 2020, eventual GILEAD $21B buyout Sept. 2020, Trodelvy TNBC approval Apr. 2021
https://www.drugs.com/history/trodelvy.html
Wino115 wrote: Given they are specifically targeting advance stage cancers refractory to standard care with no known treatment, their trial may be more streamlined. What I mean is that there won't be a "standard care" patient group to compare as there is no SOC.
I would also bet they won't mess with multiple dose levels with the first trial and keep it simple to cross the finish line quickly. They can do frequency/dosage trials later, post approval.
I would also assume, like IMMU, they would get rapid schedules and BTD since there is literally no treatments for all these patients. If the resistance bypass, VM, anti-metastatic property and anti-stem cell benefits are real, the FDA will want to get this drug out there. IMMU's initial reads in the P3 confirmed the P2 within a few months so they granted approval and then just said finish up the P3, but we don't need to see more data.
All that to say good safety and solid efficacy would be looked at as a bit of a miracle for late stage refractory. Doctors would clamor for it. So timeline could be quicker. Big maybe, I know.
Recall successful P1 into a P2 should be worth a 5x type appreciation, and P2 to P 3 another 4x. In this case the starting $ value is so low that the market cap could be justifiably higher if success is achieved. The starting base is half what it was for IMMU.
jfm1330 wrote: The best case scenario is obviously an indication with very good early results, the FDA greenlighting a phase I/II in this specific indication with breakthrough therapy designation, then priority review. In this case we could be three years away from first approval since no manufacturing problems are expected like it was the case for Immunomedics and their ADC. PDCs are much easier to make and to have a fully validated synthesis process.
SPCEO1 wrote: I think that good news would be good oncology news that allows the company to move into phase II. Once a drug is in phase II, the analysts typcially start ascribing some value to it, so that should help a little but the brokers covering the stock are not that influential so you should not get your hopes up too high. Two of the analysts have already suggested they are leaning towards icluding some value for cancer in their target prices.
The other thing that would help would be a BTD for TH-1902 or some other FDA "medal" acknowledging it as an intriguing drug prospect. That would likely be tied to good phase 1b results.
jfm1330 wrote: I am at the point that an added reason for me to see a really good news would be just to see the very positive impact on the SP. When I say really good, it's really good. The kind of news that would garantee thay will have a good business in oncology. With such a news you would see that the market would take notice of it quickly.
SPCEO1 wrote: The stock was already dead before the news of the small amount of insider selling.That is why that news had no impact on the stock price. In fact no news of any kind is having much of an impact, evidently because so few investors are anticpating any news of any kind at this point as they are not even paying attention. I am pretty sure insider buying might be ignored as well. Still, I would like to see it too.
TH1902 wrote: we get more positive Oncology news...insider selling, NO INSIDER buying to show confidence in the potential of the company and oncology trials...
BOTTOM LINE, I will DOUBLE my share count when MANAGEMENT buys shares with their OWN MONEY on the OPEN MARKET...
That is the only sign to TRIGGER my BUY...
Thanks again to ALL that share so much of your time and expertise here...I APPRECIATE YOU...