Hey Greens. Phase 3's usually last 1-3 years. The hip drug is an easier one to guesstimate. They should have data cleaned up by end of year and an FDA update meeting scheduled at least. I like the hip drug much more than the lipid drug, from a FDA timeline perspective. If the side effect profile is ok from phase 2, this is a drug that can potentially prevent early death/mortality in elderly/frail populations. I think their phase 3 will be somewhere in the shorter to mid range length, as far as Phase 3 duration goes. Not to be crude, but when the endpoints are quality of life, walking or not walking, death or no-death, it doesn't make sense to force a long phase 3. It also makes some of the side effect profile easier to tolerate if stuff is there. It's a 'better or with it, or without it' scenario. If mortality rate or quality of life metrics show promise, it could end up quickly heading down the fast track alleys, and they could just do post-marketing to really follow those people out there as the years tick on, maybe even restricting it to the sickest people before the potential phase 4 stuff is all said and done. I definitely feel we will have an FDA decision before the warrants expire... but how soon before, nobody knows. There just isn't a lot of pharma competition in the steroid market, like rich rich guys that can clog up the government process. If it can move, and it doesn't harm people, I don't think there will be many people out their with financial motives to stop it.
The lipid drug is more of a mess. There is insane competition in that space, and this would be a game changer. The powers that be, no matter how good it looks, will make the FDA process drag, imho. Look for lots of bumps in the road, regardless, and a long phase 3. Even though statins aren't great for many reasons, we have a lot of data on them, good and bad albeit. To enter that space in a lipid lowering indication, they are going to have to compete with the status quo, and claw into the market.
That's why I think they are being incredibly intelligent by looking for orphan indications, it will still be tricky, but will be harder to stop if the data is good. I expect the orphan indication fast track stuff to are only chance of seeing anything meaningful before the warrants run out. That being said, it also makes us a wonderful takeover target if the lipid data is super good. It's easier to buy us sometimes, that it is to grease the wheels of government indefinitely. Especially with the changes to the FDA process that are being hinted at under our the new leadership.
That being said, the price target question is too hard to guess, because of your second question. I can think of innocent and not as innocent reasons why we are trading at a fraction of our competition in the lipid space.
Most obvious being... outside of doctors and scientists, who on earth has ever heard of a thyroid beta agonist, let alone that isn't for your thyroid, or a non-bodybuilder that has heard of a SARM. They sound like voodoo. The SARM isn't a steroid molecule, so it will be perceived as weaker (even though it's a false premise) until data proves otherwise. Not only that, but our low float and huge insider ownership, it leaves no room for the fat cats to manipulate the heck out of it all day long, and it can never be their plaything, not anytime soon. The reason why the competition company you mentioned is trading so high, is probably just a factor of the guys who are own most of the shares behind closed doors, and what their motivations are. I'd much rather be with our company, as they have strong motivation to not dilute and to protect themselves in the current structure, and are less at the mercy of market 'forces.' If they are forced to dilute at some point to any significant degree, all bets are off. They are playing this perfectly with the way they are financing progress. Once we get known enough to where big players will be forced in, all bets are off. Once little guy traders want this stock, the big guys will not loner be able to resist the chance to get in and screw with it. There will be a big initial jump when one of them enters, and I will probably start selling some percentages of my stake about 2-3 months after that occurs... just before the manipulation stuff really kicks in. Where we are at that point, my guess is somewhere between 4 and 12 dollars. I could easily see us having a 350-700 million market cap when we one day have a pdufa date set and are waiting those last few months. I guess it al depends on how many shares there are at that point. If we hit two home runs on phase two, and get a break with how quickly the orphan indication can progress, I could easily see a 200 mil market cap by mid next year.
All bets are off though with such a low float, that's just what I've seen before with similar stuff. I made some of my original cash on diet drugs a couple of years ago, and those guys were startups who briefly attained 1 billion dollars caps. It's totally doable, but it's a long way away.
Even if we are still waiting on the FDA when the clock ticks down on the warrants in a few years, we would still be well positioned if nothing horrible changes.
Have a good one!
