I have no dog in this race, merely trying to look out for fellow Fools. I’ve watched biotechs like this come and go for just over 15 years and hoping to prevent you from making some of my mistakes.
-this treatment has not been compared to anything, so how do we know its any better than snake oil? The clinical trial arena is littered with instances where the placebo arm fared much better than historical controls and hamstrung the treatment arm.
-they changed the dosage of the chemo regimen between the first and second trial (as well as during the second trial) which significantly reduces likelihood of FDA approval.
-because of this, even if approved, its anyone’s guess what a treatment dosage would look like - no one knows what optimal dosing is yet.
-novel mechanisms fail FDA approval 70% of the time & twice as often.
-even if approved (likely <10%), safety profile will significantly hinder expansion of its label in an already very narrow market.
-somewhere between 30-70% of these patients will be ICU admits based on KITE’s previously documented ADR rates.
-1 year survival after ICU admission for those >85 years of age is 3%
-1 year survival rates after ICU admission rates for all comers is about 30%
There are stumbling blocks at every corner for KITE to be successful. In addition to the FDA, will KITE be able to produce the drug in a timely manner? This will be insanely expensive to produce - likely in the realm of 200k+ / treatment. Insurance companies will also more than likely have an ICU bill. Stop being a humanitarian for just one minute and ask yourself- why do we think insurance companies would pay for this? If your answer is because “life is invaluable” then you likely have not had much interaction with insurance companies before. Do we think they’ll pay for a treatment with questionable efficacy and tons of ADRs that will generate additional big bills?
I’d love to see this drug work, unfortunately it doesnt look like it works well. If you invest now, there is a real chance you lose 60%+ overnight. Even if they get FDA approval, they are going to need additional funds, and they will have manufacturing & sales / insurance company reimbursement issues to overcome. You can wait and see how this plays out, and if the smoke clears abit, you can still make a good bit of money with much less attached risk.
IMHO, invest in KITE only if you are willing to part with your investment almost overnight.