Actually, I've paid very close attention to the details. Depending on the number of sites, it will take a several weeks to enroll and schedule 350-400 patients. If you listened to the call, they aren't going to start the trial until they get the SPA in writing.
Filing time began at the FDA meeting per the agreement. TO get a written agreement from FDA is huge and gives a specific end game. that was the beauty of the CC. THe approval process is reduced brother.
Your sadly misinformed. the number of enrollees will be completed in less than a month IMO. You obviously have not paid attention to how long it took them to fill the enrollment on all previous studies. No sure the exact date but an educated assessment indicates within 30 days. The MI study for cartilage regen is still under review based on the 52 week time line. Frankly, it is not material. The bigger question is the end game? Optima will also be an interesting play once they present to FDA which sounds like it is going to happen very soon. What ever side of the fence, your the timeline is winding down.
According to mgmt., it will start after they receive the SPA in writing. Then the key is getting the last patient enrolled. Mid-Oct. is my guess for that last patient.
trial will be started by mid aug. The pharmas will see value of SI and they can run the MI studies later. Ampio will be bought after 12 week trial complete.
K, Your spot on. Many are negative on Mike but he is direct and at least honest. Frankly, i can tell by their tone they are very excited. The threshold is lower as well as far as the end point of the study. Did you catch that? I think bill needs to examine that part of it. I was actually surprised on the BLA and the length of the study. This company will be taken out by christmas.
Based on what they said, the estimate for the start of trial is "less than 60 days." How long to enroll 350-400 patients? When will the last patient enroll? My guess is mid-Oct. Add 12 weeks from that point to the end of the trial. A few weeks for data analysis. Filing possible by mid-late Feb. SPA may reduce the approval process. So, instead of an additional 10 month waiting period, perhaps it is down to 4-6 months. That's my read. BTW, multiple injection was intended to separate Ampion from the competition, particularly with the MRI results, that we've never heard about. How does a return to single injection create home run value?
A home run would have been acceptance with the data to-date, IMO. The SPRING study had statistical significance AT WEEK 12. Look at Figure 2 in the PLoS One paper. Note that the ONLY large separation of saline and Ampion occured WEEK 12. The confidence limits are very close Week 10. That could have resulted in failure. Week 12 saved it. Since most now understand the high variability in patient responses, especially since it is subjective, there remains a High Risk that SPRING will NOT repeat.
Furthermore, the average reduction in pain was 42%. The Minimal Clinical Important Improvement is 41%.
That is cutting it very close. Again, in Bar Or's paper.
They have finally taken control of all of the details that created historical issues. They are manufacturing 100% of the product at their site including the saline. They will have total control over all issues. They have evidently learned from the historical detail errors.
As always, MM is upfront and honest, no weaseling around issues – confronting all questions quickly and directly—how very refreshing in the current world in which we reside, to not mention unusual.
When asked if the company were for sale, the response was I am a big shareholder and I want was is best for me and thus you. I would venture to say when they get this trial done and the product ready to market, the company will have been sold. They are holding the execution cards closely now as they want to expedite the trial and Big Pharma tends to drag out trial set ups—very wise decision.
I think they have the sites picked and they are going to be very diligent. inclusive to K2,3,4 this is a home run. I am pleased they are going to do it out of their lab as well and the FDA is going to give them an immediate passage into the filing. This is really good. NOw we just need a solid study. We will know by NOV.
Great news IMO. short 12 week study and no delay on BLA. Tells me the FDA viewed the Data favorable. Using spring study model which is perfect. Considering the alternative this is close to as favorable as one can get. The Optima is a dark horse. Great data be interested to see what FDA says on that.
Optina results announced were very strong
Sounds like the BLA filing is going forward
Sentiment: Strong Buy