The facts support that the technology works -
https://eyepointpharma.com/our-technology/ - which is the renamed company commercialising the same technology has two approved products. Although Eye-point uses the 'honeycomb carrier' to slow release medicines in the eye. (Medicine as opposed to radiation)
The technology is a proven entity to guarantee slow release and predetermined time of release of the substance.
I can can very much understand the elation approval because it is a product that is so similar to a medicine but is seeking approval under a device arm. The egukatory bodies would certainly feel the weight of responsibility and no doubt wanted more patients - similar to the confidence they obtain with pharamaceutical rial data.
i do not thin this delay engendered by the nature of the product reflects badly on management at all. It indicates characteristics of optimism - which if approved will be extremely valuable for the growth stage of the company. The technology is good and sound and is vindicated by the Eyepoint story, and this explains the management optimism.
Having examined in detail the Eyepoint data and the history of the development - I accept the technology is sound. The key point that keeps me holding is that 25% or so cases become resectable after insertion. Resection = a chance of cure, non-resection is essentially a death sentence.
it would be a shame if the investment community gave up on the progression of the technology due to regulatory delays and the necessity of the regulators to be 'more than sure'. I would like to see some institutions back this through the FDA approvals and full resources provided for the Pivotal trial. Which the CE mark would no doubt follow.
(20min delay)