Some of his comments included "ebola has killed about as many people that die in Texas from drunk driving over a similar time period" and that ebola "isn't even in the top 5 most important health threats in Africa - more people are killed by malaria every day than have died from ebola in this latest outbreak".
That is what you people hyping it don't seem to get - drug valuation is a numbers game - there are not enough victims of this drug in the entire world, let alone western countries that can afford to pay for a treatment, to generate enough revenue to create a valuation worthy of your hype. Give it a rest!
Appreciate the positive outlook, but when you have a market cap of $750M+ and you are explaining on the conference call that the few hundred thousand of revenue that would have been booked on shipped but unapproved Firefly devices in the quarter would have got you to your revenue goal, you clearly don't have any better things to share. With the assumption that this deferred revenue will get picked up in the 3rd quarter and you still warn you may not hit your 40% growth target, it is just a story that just gets worse - they would have been better off not mentioning it.
Continuing that thought, I think that Arun may be out of his league here and it may be time for a new CEO or to sell the company. They clearly have a very compelling technology, but it seems to be dying on the vine. He never seems able to keep two balls in the air at once - focus on L&P and the rest of the results falter - and I continue to fail to understand the complete lack of movement in getting SPY marketed outside the US. As some of you may recall, there was an earnings call a couple of years ago where they spoke to actual SPY shipments overseas and how that offered another great growth opportunity - then nothing. Given how the socialized healthcare systems in Europe and elsewhere are focused so intensely on costs and SPY's proven ability to reign in the cost of complications, it should be a no-brainer to find competent partners outside the US. Time for a change or sell the company to someone who can truly take advantage of all the opportunities.
Although they are still on "course", I think the "market" may have expected Luna and Pinpoint to propel them beyond the 40% growth they projected at the beginning of the year - I certainly did. So, when L&P revenue increased by 300%+ (from Q2 2013) and they are struggling to get to overall revenue growth of 40% for this quarter and next, something doesn't sit right. No doubt, the bulk of this company's value rests with L&P, but up until a couple of quarters ago they were hi-liting the percentage of breast reconstruction surgeries performed with SPY and how that market was moving toward standard-of-care and a period of hyper-growth and now it isn't even mentioned? It reminded me of how when I first invested in the company, they spoke about coronary bypass procedures as offering the first great market opportunity and now it isn't even mentioned? I was distracted during the call - did they even speak to the LifeCell sales and what the prospects are moving forward?
GSA - Luna and Pinpoint sales increased $3.9M (from $1.2M to $5.1M), while total revenue increased only $3.1M, so outside Luna and Pinpoint, revenue declined. Some of that can be blamed on daVinci - is the rest because Lifecell has already bailed out?
CG "may be too confrontational" in the FDA meetings? How else are you supposed to respond when the FDA, after months of review, comes back with glaring errors in assessing the natural history of the disease and the comparability of Etep to Drisa and throwing the prospects of AA into the trash bin. The fact that he has not publicly called out the FDA for incompetence is a sign of restraint and political maturity.
"Spoken from the heart" may be correct, but you are supposed to use your head to invest. Unless you believe that this latest outbreak won't be contained and 6 months from now Ebola has spread to numerous western countries, Ebola will evaporate from the headlines as quickly as it came. The best you can hope for here is that the US govt ratchets up their commitment to TKMR and/or stockpiles some drug after another year or two of additional testing - that is not a formula for a billion $ company - besides, as the news has revealed, TKRM is not the only player in Ebola and is probably not even leading the race.
This is not an "airborne" virus and the numbers of infected people are just not large enough to warrant a large-scale program that is going to drive the valuation of this company beyond its already lofty $300M+ market cap. Malaria kills a million people a year - why would you think Ebola should warrant a huge financial commitment from various govts, just because a couple Americans became infected?
McNary Jen found a twitter post she made in Aug 2010 (a year before Max started in the trial) lamenting the fact that she had to pull out one of Austin's old mobility scooters, because Max was having trouble keeping up with the other kids. Four years later and after 3 years on Etep she reports that Max hasn't used a "mobility aid" in two years. I'm sure it's just a placebo effect!
The clinical "significance" achieved was a comparison between the treated group and the placebo-delayed group at wk 48. Since the placebo-delayed group has now been on drug for 120+wks vs 144+wks for the treated group, the relevance of that comparison has lost its meaning - both groups are fully "on treatment" at this stage. Whether the differential in 6MWT changes remains statistically significant at this stage of the extension trial is meaningless - it s more meaningful for both groups to remain as stable as possible.
Beyond the error rate is the risk of an error - the overdosing risk is minimal w Zalviso, while the risk of an error (mechanical, nurse programming, dosage, etc.) w morphine is much greater. A few lost pills is not going to put patients' lives at risk.
simp - the premise of your paranoia is that there is some confidential secrets that would be detrimental to the share price. Saying he had "serious disagreements" with the guy that just fired him is hardly a revelation. If some short comes forward with some "confidential" dirt over the next few weeks, do you really think it won't be hard to attribute it to Krieg. Either way, your belief that there is some dark secrets at the company that the shorts will be trying to squeeze out of Krieg is just another one of your self-induced fantasies.
What "public quotes" are you referring to? Did these quotes include confidential information? You're on the wrong side of the coin on this one simp - if you really think AK is going to give or sell confidential information to short sellers, you're more paranoid than I thought.
Are you implying that the reason the walk test scores are fading is because the "down time" created by the dosing schedule leaves dystrophin production gaps, where muscle is continuing to be destroyed? My knee-jerk reaction was that it didn't make sense, given how long it took for dystrophin to build up (24+weeks). Who knows - unless they build an oral or IM formulation, we may never know. They must have some idea from the animal studies how durable dystrophin is in the body (once produced) - i.e. if Etep allows dystrophin to be produced for 24 hours, but the produced protein only survives for 24 hours and you have 5+days of no dystrophin in the body, then that would be a problem, but I don't think it plays out that way?
Whether they have started recruiting/screening kids, yet is highly contingent on whether the FDA has figured out their position on dystrophin measurement - until they sign off on methodology (that will have to be used for baseline measures, as well as post-treatment), they cannot start the process. Not sure how many sites they were targeting, but regardless, with parents falling over themselves to get their boys in this trial, it is not a question of "recruiting", but a question of screening to get the right profile for the trial. Either way, SRPT has established enough connections in the DMD, community to get this trial enrolled quickly, so if there is any delay here in getting the Phase III trial started, it is most likely due to the FDA, once again.
if they get a complete response letter due to some minor issue - IOW, the FDA signs off on efficacy and safety, but wants some additional information on the dispenser, manufacturing, labeling, etc.??
Part of the reason that nobody cares is that the company does not have the capital to take Asonep into a "pivotal" trial, so the dilution overhang will limit any interest, even if investors found the early results "compelling". If they partnered it with some upfront money, that would change the equation, but for the forseeable future, the Asonep story will not change the equation. Isonep is a different story, since the pending Phase II results involve a potential buy-in by Pfizer (or whoever buys their interest) and provide the company the capital to avoid dilution at the same time Isonep is validated as a blockbuster. Unfortunately, it seems as if we will have to wait until Q1 of 2015 for that story to play out.
ml - again, he was hired to expand the platform, not work on Etep. The rumor on twitter is that he made a power play for CG's job and lost - that has more credibility than him sabotaging or dragging down the Etep clinical path. There was never any indication that he was directly involved in Etep at all, so the speculation that it has anything to do with Etep is off base, IMO.
The company didn't "point" to anything and he was hired specifically to expand the platform, not work on Etep. What a moronic comment.