The insider buys as a group like this are as clear a signal that they think the stock is undervalued on every level. In my opinion, MACK is a buy now on a fundamental basis as well as a 'future events' driven basis. If they hadn't screwed up the financing so badly, the price now would likely be somewhere between seven and nine as opposed to four and five.
It's a fun exercise even if no one's predictions actually ever come true.
The major 'milestones' over the next six months are as follows:
1. Phase I MM 302 results(this Friday). Any reassurance regarding safety and any indication of efficacy would
be very bullish. This is a 'sleeper' in MACK's quiver, and could be a very important drug vs breast cancer.
2. Clarity on whether/when/how Sanofi will take MM121 into Phase III. There may be a milestone payment
associated with this, but I'm not sure.
3. Business Development: Management has been saying for months there are 'multiple' business
development efforts underway, which in all likelihood means out licensing of further compounds, and the
payments and validation the deal(s) provide will add credibility to the MACK story.
4. MM398 Results. This is the biggest event of all, and we'll just have to wait and see what the numbers are.
There is no guarantee the trial will be successful but most analyses I've seen are very optimistic. If MACK
gets a big win here, there will be a very strong effect on the price.
5. MM121 results in 'triple negative' breast cancer. There is not really ANY good treatment for this condition,
and if the Erb3 agent proves useful this is hugely bullish, and would further enhance the growing reputation
of not only MM121, but the entire Network Biology platform.
If MACK hits on a few of these in the next few months it's hard to see the stock in single digits, and if the 398 results are as good as some of us predict then there could be a very dramatic revaluation of the company. Take a look at the chart of any other comparably sized biotech and what happened on the day a drug had a better than expected PIII trial result. Those days are rare, but the ones we biotech investors live for.
I highly doubt it. The DSMB(Data Safety and Monitoring Board) would halt the trial way before that because of the obvious increase in efficacy.
That's a nice thought, but the real focus should be on more realistic issues, like how many patients survive one year(a KEY piece of data), whether one or both arms of the trial meet their endpoints and by how much, etc.
MM302 is a repackaging of a well known drug, so the chances of a big trial miss are remote. Doxorubicin has been around for years and works great. It's the side effect profile, heart toxicity issues mainly, that have kept it from having wider use. Plus, it's only in Phase I for heavens sake so ANY indication of efficacy would be a very positive signal. Phase I trials are really safety trials.
We won't know until the announcement is made, but the odds are in favor of a positive announcement rather than a negative.
The deal doesn't 'end' at Phase 2.
From Phase II on Sanofi controls and pays for the Phase III(s) and when they are done and the product marketed they must pay MACK a percentage of sales. No one knows exactly what the number is, but typically it is anywhere from 10% to 20%. Sanofi has worldwide rights to MM121 except for a 50 /50 comarketing agreement in the US with MACK.
It's not accurate to report that there are 0% alive at 3 months. It's actually around 50%. The MEAN survival is ~3months which means HALF are dead by then, and half still alive.
You didn't post a link on ihub and the link you supposedly posted on Stockhouse is nowhere to be found. What on earth are you about?
I've learned over the years it does no good to tell anyone on a message board what to do. It just doesn't work.
I try to post only what I think is useful and by doing that set an example for others.
Just search by poster if it becomes too onerous. I will post whenever I think I have something to add.
If we end up with nearly 7 months average survival in refractory Pancreatic cancer patients on 5 Flurouracil it will certainly be a surprise. I don't know of any study that gets even close to that number. So, to repeat the mantra: possible, but not probable.
I do think it healthy to discuss every possibility though. Many thanks.
Yes, we won't know the 'real' story until the data is finally revealed. Many of us have done a lot of work to come up with all possible scenarios, but we are 'outsiders' and don't know the whole story. I'm comfortable with my conclusions, but will be a lot more comfortable when the results are finally out.
If we assume that the delay is because of an anomaly in the control arm I'd estimate they would have to be living on average something like seven months or more. It's possible, of course, but highly unlikely. Most people on therapy for 2nd line pancreatic don't live that long.
You are absolutely correct, and I didn't go there as I don't want to seem like I'm overhyping the story. Yes, diagnostics will be a big help and yes there will likely be many other indications for 398. It will take time and money, and for our intermediate term purposes I was concentrating on just the first goal in pancreatic.
Geez, two successful Phase II trials in a novel area where MACK has a lead over the competition for a multi billion dollar prize---MM121----and a (probable) upcoming successful Phase III trial in the 2nd quarter 2014---MM398---are just nothing, eh? Ahem!
Biotechs can achieve very significant valuations far before they market anything. If you invest in this arena and don't know that already, good luck.
It's healthy to play devil's advocate, and you make a good point.
The discussion I have heard in conferences is that there was an initial delay when the second arm was added in 2012, but that enrollment was fully underway by the second half of that year. So the models I and others have been constructing start in the third quarter of 2012 and go to mid August this year assuming a relatively even enrollment each quarter.
But even if there WAS a bolus in July / August this year, the fact that the results won't be announced until 7.5 months(Aug 13th to Apr 1) after the last patient was enrolled is cause for comfort. As I've said, the average control group life span in this condition is 3-4 months, and so it would appear that both arms of the trial still hit their marks even in this unlikely scenario.
The $5 / month fee is obviously just a teaser to get folks to come in and try the system. The idea is to not have any barrier to entry, and having tried the system and liked it the user will automatically be upgraded to the higher priced plans the more he uses the service.
There are a lot of ways to skin this cat and this is the way the company has chosen to do it. We'll see what the market thinks of it as time goes on, but the real excitement here comes when the transcoding and streaming users see what's happening and why this technology changes the rules of the game. The company will begin selling site licenses next year and that is where the real $'s are. They will go for $50k to $5M, according to the CEO in a presentation I listened to online.
The best part of the story is that the date has been pushed back at least twice.
As I remember, the company was saying last year that the results would be out 'by the summer' of 2013. Then, earlier this year during a conference call they moved the date to the fourth quarter. And in the most recent conference call the date was moved not to the first quarter of 2014, but the second. That is a very long delay to announce, and effectively pushed the date out more than three months.
So if the control group is indeed living longer, they're going to have to set some sort of world record for longevity in the 2nd line pancreatic setting to perturb the trial results.
And I am completely open to any contrary argument here. Please feel free to challenge this. I have asked many to do so and haven't found anyone who could shake me out of my conviction that the drug has very good odds of success.
I've heard that number mentioned by a couple of the analysts. I can't attest to it's accuracy, but I presume they know what they are talking about.
No, I mention that pretty clearly in my post. Read it again.
There are a fair amount of studies in 2nd line pancreatic cancer and median survival with 5 fluorouracil is between 2.5 months to 4.8 months, with 4.8 as an outlier.
Yes the control group could always be living longer, it's just that there are no studies out there with a worrisome number.