The PFS is not enough to get approval. In 2013, Tivozanib is the star example of this. It's structurally very similar to Cabo but it blocks all VEGFR (1-3) but not MEt. It met primary endpoint with flying colors in mRCC for "tivozanib versus sorafenib in the first-line setting" (TIVO-1) but it did not improve OS due to adverse events (hypertension deaths). The board voted not to approve it.
Drugs of today (Barcelona, Spain : 1998) (2013), 49(5), 303-15
FIRST IN LINE!
While we have reason to expect good PFS based on similar structure compounds, the FDA could ask for OS data if it's not looking sufficient enough at primary read out. It's possible we would have to wait another 19 months as a result. It'll likely be dependent on adverse events. The upside is that Cabo is advertised as selective toward VEGFR 2 but also hits VEGF 1 which is probably a result of trying to also target MET. They probably were trying to get all 3 but as a result, the profile might be a bit different.
The outcome of this could be big but not a homerun but is a reasonable bet.
I'll have to check out CYTR. Glancing at it, it's "delivery enhanced". How much of it would they own? Doxorubicin appears to be "generic" now.
You like risk for sure. I wouldn't consider NGD or ESPR but ESPR seems like a potential pouder keg. Such a run up on phase IIb data for a company with no product is questionable. It'll be a large study for the drug in phase III, they'll be dumping a lot of cash into it and will need a way to finance it. After glancing at their financials and at the risk of sounding like semanresu, $40M in cash burning $10M a quarter and not even starting phase III would cause me to realize any gains I had.
It would be a different story if they were closing in on results of PIII but they will dilute, borrow and spend for years before the results are out. It's likely to take nearly a year to plan the next study much less execute it.
I'm @ $3.47 on the price.
Am I correct in that this is an additional draw from the available loan amount from 2010? Or is this part of the “conversion” part?
I’m wondering what they knew about the data to agree to 120% of the 10 day volume adjusted average.
The way I see it, the stock is worth $3.50 tomorrow or until they settle.
Assuming I understand the problem and tomorrow is exactly the same as today it'll be 120% of $2.89 ($3.47).
Looking at the peak volume of the last 10 days: $3.52 (1.2 X $2.93)
Looking at the average volume of last 10 days : $3.50 (1.2 X $2.92).
The thing that will drive it lower would be low volume but $3.52 is the upper limit.
I'm not particularly worried about Tivantinib. It should be highly selective but it's toxic outside of on target effects.
Clinical Cancer Research (2013), 19(9), 2381-2392 "Tivantinib (ARQ197) Displays Cytotoxic Activity That Is Independent of Its Ability to Bind MET "
In that article they state "the preclinical data do not support a clear role of MET in mediating its pharmacologic activity," and it is better with the ras mutation. More quotes from the paper: Tivantinib inhibits the growth of tumor cells not expressing MET or not dependent on MET for proliferation Previous studies"; 'Tivantinib does not inhibit MET autophosphorylation in tumor cells"; "Remarkably, MET was found in a completely dephosphorylated state in these cells before HGF stimulation, thus representing an ideal target for tivantinib. In spite of this, tivantinib failed to inhibit HGF-induced MET tyrosine autophosphorylation at either Tyr1234–Tyr1235 or Tyr1349 at any concentration tested"; "Deletion of the ATP-binding cleft of MET does not impair the cytotoxic activity of tivantinib"
Just glancing through, I have my doubts that it's activity is due to "MET" binding and may be more of an off target affect that amplified the effect and produced the results they were looking for. i.e. I think it's going to lose becaue they didn't separate the problems.
Most oncology drugs will be toxic because of on target affects but when you add off target affects, I would think we should be moving away from that when possible.
Other statements about Tivantinib:
"No drug-related worsening of liver function or performance status occurred, but one Child-Pugh B patient experienced drug-related bilirubin increase. Four patients had drug-related serious AEs, including one neutropenia-related death. Haematol. toxicities were more frequent than in previous tivantinib studies but were manageable with prompt therapy"
They might have issues with explaining away off target effects.
Because that seems to be norm buyout price. It gives the company being bought out profit to satisfy the original investors and allows for profit to be made on the remaining patent life with room for new competitors.
Personally, I wouldn't buy on it alone. That's why I put a price of $1.29 on it previously. I have accumulated based on that $1.29 base plus potential results. Positive METEOR puts me at 2.82 +/- 1.02 pps. with a potential for a future buyout in the $15 range. I'd settle for $7.
It's like he's an agent of deerfield to paint companies bad so they get a lower price on the stock.
search "Exelixis (EXEL) Highlighted As Weak On High Volume" by thestreet. They covered it and financials. Painted it bad.
This truly saddens me. They'll do research to reduce the cost of technology but to actually advance science, it greatly dependent on academic research. Fundamental biology is key to truly novel therapies but it's usually not a part of drug discovery.
I'm not ready to buy into them. I'd have to do much more research on the science and the bad news this morning it not favorable.