Sharon di Stefano

Biotech, healthcare, small-cap, special situations
Sharon di Stefano
Biotech, healthcare, small-cap, special situations
Contributor since: 2012
No, what this means is that PLX Cells may reverse necrosis, because of their nature of arterial remodeling as you intuitively suggested Dr. Mitchell’s work should draw others to explore the value of PLX Cells in disease indications that associate inflammation with anti-angiogenesis.
Returns to investors in biotech take time, and there is a risk/reward ratio that can be significant, so be patient. Pluristem is making meaningful headway in its trial in disease indication that would ultimately address large worldwide markets. The management is dedicated; they have a manufacturing facility for cell therapy that is ahead of anything yet seen, and certified by regulators, which I believe will draw pharma partners.
I thank everyone for their comments, and would like to add that Rexahn impresses me as a company that does right by its shareholders, from well-run clinical trials based on sound scientific research, to setting and reaching corporate and regulatory milestones, to providing active news flow to investors. Their decision to seek approval this June for a reverse split is a good choice, perhaps leading to listing on NASDAQ, home of the majority of biopharmaceutical companies where Rexahn will be among a recognized peer group. Although recent reports by Brinson Patrick and Roth Capital peg a target of $3.00 per share, I am more optimistic and believe that Rexahn shares hold unrecognized value and could move much higher.
Enigma, I agree with scuba - under seven months for a reply on the Orphan Drug application status. Pluristem's relationship with the agency seems to be in good working order.
-Sharon
Scuba, with two Orphan Drug designations already achieved, I don't see why this one would be denied. I am always impressed with Pluristem's good relationship with regulators, the FDA being the most stringent.
-Sharon
You are welcome.
-Sharon
Hi, STC. I think you are correct and also pay attention to how fast they are moving within regulatory bodies. That says a lot.
-Sharon
Thank you and my deepest sympathy for the Missus. How old is your child? I'm curious as to the treatment prescribed. It is truly a tragedy that medical science is not more formally addressing this disorder.
-Sharon
Thank you for the correction.
As the relative of a child with juvenile diabetes who does not particularly like needle-sticks, I welcome the day Mannkind, or anyone else, perfects an insulin inhaler. Our family was devastated when Pfizer’s multi-million dollar research efforts could not support use of Exubera in pediatric patients. The FDA must tread lightly when dealing with clinical trials for pedes. On the one hand, drugmakers can be awarded six extra months of patent protection for testing medicine in children but on the other, the FDA must weigh whether smaller doses of investigational drugs given to pediatric clinical trial patients is indeed ethical.
Like journalists, physicians tend to see things in black and white. Afrezza, like Exubera, ultimately ends up in the lungs and doctors don’t like that. Nor, apparently, does the FDA. Platforms with fancy names and pharmacokinetics do not excuse the fact that inhaled drugs other than those for asthma have had a hard regulatory time. Investors may never know the true nature of the relationship between the FDA and Mannkind before, during and after the complete response letter, but as Americans depending on the only agency that protects us, we must abide by what they say when considering approval of a new drug.