I disagree with you on the announcements, but I guess it depends on what your definition of "solid good announcement" is. If you are referring to FDA approval, I would say that is more earth shattering than solid good, and will cause a substantial overnight re-rate with earth shattering buying pressure.
Looking at the announcements I've heard:
- FDA said that GvHD CRL potency assays appear to be reasonable ( which is the requirement of how they need to appear in the approval guidelines word for word).
- The company said that they have the data in hand that ties in MOA in Vivo and in Vitro which is another CRL item identified by the FDA that also matches what the FDA said they were waiting for as a next step.
- New study on the GvHD results demonstrate superior efficacy of Remestemcell - In the severe GvHD sufferers with the lowest chance of survival ( 10% chance of survival vs 64% who were given Remestemcel.) - further proves supreme efficacy in the BLA resubmission.
- Company has just said they expect a timeline of BLA approval later this year.
- FDA have asked the company to identify the sub group that would give the public the most benefit as a treatment from the CHF phase 3 trial. 37% 3 point MACE reduction or over 50% if they were inflammed. Again demonstrating higher efficacy that will aid in approval.
- FDA agreed a 12 month instead of 2 year back pain trial, and for pain to be primary end point, where they insisted on movement and pain composite in the previous trial. This primary end point should be easily hit, and this trial is the cheapest to run of all of the trials due to the very low cell count required.
None of those announcements existed 12 months ago. They are all due to the stage the company development is up to today. I agree if you are elderly and might not be around in 12 months then I would question why invest in anything .... Shouldn't you be spending it all and enjoying life?
I feel the company is on the edge of something remarkable. All the phase 3's are complete. All of the data looks very, very positive - even in the new indications. I fail to see how GvHD doesn't get approved this year. The company has all the items required in the CRL, has been addressing all of them in talks with the FDA at the same time.... it is all heading in 1 direction except the share price which has gone the polar opposite direction.
For me - I have a looooong time for them to get this approved before I need to withdraw. I am sitting on a loss if I sold today, but I've also averaged down so in the long run I will maximize profit. I do think that GvHD approval is the key here. Once a drug is approved for use it is much easier to label extend it into other areas. Ie - A single Crohns phase 3 would be acceptable with probably 6 week to 3 month data (since that is how long remission took).
For $1 you might find an investment that pays more until MSB get something approved.... thereafter I don't know of anything else with this much market potential..... Much safer bet to buy in after the FDA has approved the product... but then you pay a premium and loose some of the profit in the process.
(20min delay)