Hi Spidey,
What I mean by all of the changes in the approval processes is the whole gamut of fast track type designations. Fast track, breakthrough therapy, accelerated approval, orphan drug status, right to try, and whatever else I may have missed.
All of these, designed to get these innovative products to market, quicker than the process we have endured to date, without anything but ARS in our sights within one to two years. And that's being optimistic to say the least.
So again, if Celularity has great results in their secondary targets that are similar to CLI, could they not get it conditionally approved, while they do the study? I truly think it is a real possibility. Especially as more of these products become approved.
I not quite sure how you think have an ex FDA commissioner on your board will not give them an edge to get any of these things moving quicker than us. Deep connection in every aspect mean nothing? Which one of ours do you want to compare them to? Take your pick and try.
You do t thing $250 million will last that long. They got that in a heartbeat. How much trouble do you think they will have doing additional raises, if needed? But yet somehow want to believe our management has enough to bring all 3 to trial? I'm sorry but that's almost laughable.
What have they come through with that gives you any trust at all to believe anything they say? A specific question to you. What do you think of Zami stating they made most milestones? Does that help in your belief in their trust?
I've asked you many times to no avail (or response) about the miss on preclinical data on Fukushima or NYBC. Almost 9 months late on them right. Mouse studies where enrolment is not an issue? Almost 3 months late on HCT interim results right. Pretty severe indication where you think a consistent enrolment would be attainable. Are these the kind of topics that lead to your optimism and belief in them?
How about the manufacturing edge that has all but disappeared. What's your thought on that topic. You think others have figured out ways to manufacture these cells on a commercial scale? I've shown links in the past to support my argument. What we have now is a higher margin as we would not need to outsource this. Only beneficial of we get a product to market. Do you think this was an enormous missed opportunity on the manufacturing edge. Could have been a leader as they had this ability long before anyone else did.
Or the one measure in clinical design trial. Like I said before, why is it good for the presentation but not where it matters. It's pretty convenient just to say go ask management, or now that IC may be be that important, as it's the CLI that will show the results. Celularity will see those results first. Not on a study for CLI, but on the the DFU study. The amputation free timeline. The same one that engulfs 4 out of 6 of our outcome measures in the study, that we will see one year.
Or how about their impending bonuses for the year? They going to be deserving of these ones as well? Is this the norm in baby biotech that one claims. That vision of them sitting around eating matzah balls will forever be ingrained in my brain. Kind of like Jabba the Hut. Sitting there laughing at shareholders, discussing the upcoming lottery. Thanks EichKing.
There are many other topics I can bring up as well. These are just some of the questions consistently asked with little to no response. All brought about with new and improved information to substantiate the claims further. We get little to no info from the company itself, so this is all we can go on.
You want to think that nothing much is said in these conference calls that companies do. Listened to Braintorm's the other week. Lots of good information. Best was them giving an actual enrolment number to date of 30 for their phase 3. Have we ever gotten anything like that. Only with IC eventually, when it was years late and hard for them to stay silent on that.
Of course profits would be substantially higher if they go it alone and make it. Only problem is others may make it there first. We going to be able to compete with the big boys with a similar product?
The one thing that all of the beliebers here have done, is make me look at a lot of other companies, trials, the biotech industry as a whole. There is competition everywhere and in every indication. We were supposed to be the pioneers many years back. This leadership has wasted two years development time chasing manufacturing that they didn't pursue in the end. Then studies on multiple indications that sit idle to this day. It is evident that the learn as you go that many are comfortable with here, has not paid off. But magically, this year it will...at least until they push it to 2019 being the "year of the shareholder".
I will tell you one thing. If these clowns are all around after the AGM, I will severely reduce my posts here. You guys would all be deserving of them and will leave them for you to enjoy. I plan to only have a relatively small number of $2 options until they make it or break it. Been doing well on other companies I have researched. Ones that actually move in a direction other than sideways, with a little down thrown in. Management and board will be something I look at as I learn by my mistakes. Contrary to most people's beliefs here, they do matter.
AI
