I will bring the conversation over here where it belongs. You should know that I can't write so my post was about looking at the stock and not about buying into the stock. But if I did, I would always buy at the low and sell at the high.
I looked at the stock yesterday. I did not look at all the links that John posted (Thanks... I think), all 3 zillion of them. So I am not claiming anything about thoroughness, etc. At current price, it is around a $65m market cap. The issue about this stock is not efficacy but safety as you pointed out. I think they will hit the efficacy button but not sure about the safety button. PSDV obviously knows the issues and so therefore the low dose arm of .23 microgram/day (.45 is the high dose arm). They are keying off of Retisert(?) which starts at a release rate of .6 microgram/day then goes down to .3-.4 after about a month (I think?). So the high/low arm approach basically brackets the Retisert dose.
B&L tested Retisert in Diabetic Macular Edema (DME). They stopped the drug for DME (as far as I can tell) because of safety, Intraocular pressure (IOP) and cataracts. In one trial by year 3, 33% of the patients needed surgery for IOP and 95% of the patients needed cataract surgery. Retisert is approved for Chronic Noninfectious Posterior Uveitis, which is a different beast. The only other treatments I know of are all like Retisert, steriod based. I think some docs use like systemic methotrexate, etc. for 2nd line but these alternatives to Retisert all have their only serious issues. So there is a place for Retisert in CNPU.
In DME, we have lasers and probably Lucentis and Avastin, etc. Competition brings the focus to safety. That's why Retisert is good for CNPU but not for DME.
PSDV's drug, Medidur or IIuvien or whatever they are calling it this moment, lasts for 36 months in the eye. They are hoping that by lowering the dose and getting the implant far away from the lens, they can get away from the safety issues.
The issue is long term safety not over 3 months or 6 months, etc. This device lasts 3 years. Removing the insert is not something that should be part of the regular treatment plan. They are giving updates from the ongoing PK trial that is running with the phase 3 trials, it has a small number of patients in what they are calling low/high arms. At 12 months, IOP for low dose looks great but no data for cataracts. We all know when they leave something out, it ain't a good sign. Looking back, at 3 months, low dose had 5% cataract rate and at 6 months, low dose had 10% cataract rate.
Why are they hiding the cataract numbers at 12 month when they had PR'd it before?
My guess is that Lucentis, etc. will be proven to work fine in this indication. We all know that Avastin is going to be cheap. The benefit of this device is one shot, 3 years. MAJOR benefit but must be balanced by the safety of the device. Let's assume low dose works, at some % of cataracts, they won't pass the FDA. And at some lower %, they will have trouble competing I am guessing.
I wonder how widely docs are using Avastin for DME right now?
The 18 month update is right around the corner. I am sure the company is hoping that the cataract numbers stay put but given the nature of the drug interaction, I would expect the number of events to go up over time all the way to 3 years.
Valuation is the key over time. Short term, the 18 month data rules.
I am not claiming to be an expert or that I have been thorough or that I am right. Just a quick shot at the goal of understanding what is going on. Good luck. |
