PAIN RELEIF IN MULTIPLE INFLAMATORY CONDITIONS, SINGLE OR MULTIPLE INJECTIONS.
OAK, OA Shoulder, OA Hip, OA Hand, Tendonitis, Bursitis, etc. For now forget about Crohns and COPD, need to reformulate, more complex. Stay with the simple indication add ons for pain relief in inflammatory conditions. Once OAK is done, the route to approval for the add ons will be less time consuming.
Big market with single injection....... if dosing regimen is multiple injections, bigger market. Big pharma can easily see this picture with the data to date (assuming Step is positive).
Crohns, COPD, cartilage repair all great potential, longer term, value still in question.
Stay with a simple clinical expansion program to get the most bang for your buck!!!! Big pharma will realize this and strike sooner than later.
When the hell will we see the STEP results??????? The start of it ALL!!
I look at it from an acquirer's point of view. Would I put an offer in before or after STEP? The STEP results will solidify if this is going to be first line minus regeneration results. The company has manufacturing ready so it's a matter of acquiring this company before it starts working on other applicaton sites. Then there is optina, which has absolutely destroyed my investment thesis for other DMA companies. We're looking at a pill that has equivalent if not better results than implants. These two products are moving very quickly through regulatory pathways which is exciting!
"a pill that has equivalent if not better results than implants" - Is there a reference for that data?
Lucentis and Eylea are standards of care with FDA approval, which led to a dramatic decline in interest in Optina from patients other than those that were resistant. That is PDGF-related and is now being addressed by Fovista. You might be referring to the dexamethasone implants? Allergan just received FDA approval for Ozurdex. But, it is invasive, so if Optina shows equivalent results, we will most certainly have a good day.
"The mean ETDRS (Early Treatment Diabetic Retinopathy Study) value went from 18.80 ± 11.06 (T0) to 26.15 ± 11.03 (P = 0.04), 28.15 ± 10.29 (P = 0.0087), 25.95 ± 10.74 (P = 0.045), 21.25 ± 11.46 (P = 0.5) in month 1, 3, 4, and 6, respectively."