The posters are now published - with MRI image on one showing how recording changes in joint space (decrease in space indicates worsening of OA). Just Phase II (like STRUT), including KL2 and KL3. Now recruiting for N=400 Phase III. Having competing OAK trials concurrently recruiting may slow PIVOT enrollment.
"Radiography is currently the “gold standard” for knee OA trials However, while MRI is still considered by regulatory agencies as exploratory, it can provide more comprehensive information on articular tissue pathology than radiography . Although overall sample size is too small to form definitive conclusions, exploratory analyses of MRI outcomes suggest :
1) Treated subjects appeared to show no substantial degradation in mean cartilage thickness at Week 12.
2) The area of mean thinnest cartilage showed a possible trend towards increase in the 0.03 mg and 0.07 mg cohorts at Week 12 .
3) Radiographs measuring the change from baseline at Week 24 in joint space widening show no change in the 0.03 mg cohort, an increase in the 0,07 mg cohort, and a decrease in the 0.23 mg cohort, with the Placebo group also exhibiting a decrease
13F due date of NOv 16 is approaching. Vanguard filed today (AMPE is less than 0.01% of their holdings).
AMPE also filed proxy was filed today to approve executive compensation
Largest owners and recent 13F's:
ACT Capital Mgmt LLLP (Dec 2014 13G) 7.5%
Knoll Capital Mgmt LP (Feb 2015 13G) 6.5%
Vanguard Group, Inc. (3Q 13F) 3.0%
Noven Financial Group, Inc (3Q 13F) 0.49%
Something odd with Regal Inv 13F: they own 1 share of AMPE.
New study uses more sensitive Response Rate for comparing HA to steroid and saline injections. No responder rate was given for SPRING. STRUT had 79% vs 47% for saline, but obviously this was not reproduced in the larger STRIDE study. This new article would not include CINGAL (combined HA+sustained release CS). From Clin J Sport Med. 2015 Nov 9
"Our position statement on treatment of knee OA with viscosupplementation injection [hyaluronic acid (HA)] versus steroid [intra-articular corticosteroid (IAS)] and placebo [intra-articular placebo (IAP)] is based on the evaluation of treatment effect by examining the number of subjects within a treatment arm that met the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) criteria, which is different and **more relevant than methods used in other reviews** which examined if the average change across the treatment groups was clinically different.
... those subjects receiving HA were 15% and 11% more likely to respond to treatment by the OMERACT-OARSI criteria than those receiving IAS or IAP, respectively (P
cutoff by the LessThan sign once again - thanks to outdated yahoo tech...
"LessThan 0.05 for both).
In light of the aforementioned results of our NMA, the American Medical Society for Sport Medicine recommends the use of HA for the appropriate patients with knee OA."
To be determined, but see good posts by jd and others on mechanism and valuation estimates.
While exceptionally thinly traded, the price has dropped from Oct 30 4.50 to 3.30 today. What happens when it gets distributed is another matter. It's unknown if any of the largest shareholders of AMPE will want it or what the large short position means. I don't want the ca.23K shares in my accounts and would rather sell, invest elsewhere, dealing with whatever tax consequences occur this year.
you are receiving shares in a shell company...a shell with limited cash and two brothers in key roles...I think your strategy is spot on...my prediction is AYTU shares get crushed. no other reason to spin it off. if it were worth anything MM would have kept it himself
Can you quantify soon? Is it possible we hear about the final patient injection at the same time we hear about the sale of optina and the dividend you mention? Next week would be nice.
I usually dont respond to such ignorance and lack of knowledge but you obviously need to get back into the school books son. You have to understand the strategy these small cap biotechs take and what your seeing is very strategic. Please have something of value you either way vs. waisting your time OUT
They don't need to. Most bio tech's use that a positive sign. But these guys are so dead quiet one can't help but think there's a big announcement coming.
Update from WhaleWisdom.
Susqeuhanna Intl Group sold about 40% of their position last Q. They still own 0.6%.
Blackrock Inst Trust was *changed* from selling all to still holding 2.3%.
New 13Fs for significant holders:
Blackrock Inst Trust 2.3% Sold 117K shares
Susquenhanna 0.6% Sold 238K shares (AMPE ranks 5917th top holding)
Geode Cap Mgmt 0.4% New holding
thank you for your reply. I always enjoy reading a fact filled rebuttal. allow me to summarize your case "this is awesome, trust me, because I know a lot."
I'll ask you two questions: how many shares of AYTU will AMPE own post spin? How many AYTU shares will MM own after the spin?
if the answer is zero, then please reconcile why MM, who is one greedy guy and if anything, is focused like a laser on enriching himself, would give away such value?