hI @col69,
yes, industry sees the future.
But the FDA is still playing catch-up e.g. the swathe of new Guidances on cell and gene therapies over the last 2 years. And they're holding that line for us & we're right there at the head of the queue.
See, for example, the CRL they chucked to Abeona Therapeutics on Monday night for the company’s BLA for prademagene zamikeracel (pz-cel), which is a cell-based therapy under development for treatment of recessive dystrophic epidermolysis bullosa, a rare disease. No favours though. The CEO insists that the CRL says nothing about efficacy or safety but their PLI had a list of the dreaded "observations".
Cheers
GLTA(LT)H
Valuation, page-16
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.57 |
Change
-0.210(11.8%) |
Mkt cap ! $1.792B | |||
| Open | High | Low | Value | Volume |
| $1.72 | $1.74 | $1.52 | $15.63M | 9.716M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 5127 | $1.57 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.57 | 39613 | 3 |
View Market Depth
| Last trade - 16.10pm 15/11/2024 (20 minute delay) ? |
| MSB (ASX) Chart |