What can I say.... I won't be reduced to an ad hominem debate with you, instead for the benfit of holders who actually care about facts - here are some.
1. The press release you just posted does not state anything about bioreactors.
2. Advancing and investing in manufacturing could include methods to increase yields ( which they have been actively patenting ), or increase the number of growth cycles to increase yields and things of that nature, not necessarily growing in a pot instead of a tray - although we know they are and have in the past invested R & D in this area.
3. I have never read a company press release stating they must have 3D in order for any of their products to be sold..... ever.... in any document.
4. GvHD they are only looking to target 50% of the possible market, which is only approximately 300 children. They have already run over 1000 people through trials using 2D. There simply is no NEED to make 10,000 doses if they are only selling 300. It is a fact.
5. For CLBP, the indication uses 1 / 25th of the cells that were used for the DREAM HF trial, which was manufactured using 2D techniques, and could have treated 9,000 CLBP sufferers. 9,000 CLBP doses even at the insanely low price compared to the other treatement costs of $20,000 ( which IMO is underpriced ) per treatment is still $180 million USD, of which about 1/2 could be profit, easily enough to fund a swimmingpool of bioreactors, for when sales increase to 100 - 200 thousand patients, ie when it's acually needed.
6. The reason I am more interested in CLBP and GvHD, is because there is potential MSB gets a signal from FDA within the next 6 days that GvHD in children is approvable. If not the adult GvHD trial is about to commence, which again on paper looks to be a superior product to Jakafi based on the resutls. In addition to that, CLBP is also about to recruit very shortly, and all they need to do in that trial is repeat the same results from the previous 2 trials, which already look consistent. The strength in that trial is the realization of the long term loss of efficacy against people who had years of scar tissue development vs .5 - 5 year sufferers that responded better to treatment in the previous trial. I expect there should be yet another improvement in efficacy over the phase 3 and the phase 2 trials as a result of this.
7. CHF is in another league. It appears to be an amazing treatment, but is extremely complicated, technical, and time consuming when compared with IV GvHD treatment or day clinic walk in walk out back injection, so I expect it to be vastly more difficult for the company to penetrate that market without a partner who is already in that extremely complex and technical place. I havn't even mentioned 3d Bioreactors yet, because I can't imagine how many hospitals in the USA right now today even have the capability to inject a needly directly into someone's heart, or what type of throughput a generic hospital would have. I think CHF will be a much slower startup when it gets approved, and take significantly longer to train the specialists verses the other indications for this reason.
8.The company have already stated going it alone is an option for them for CLBP specifically, and is the plan for GvHD.
Based on the low cell count, ease of use, investors from surg centre, I agree with them.
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