C3 clarifies TGA intention to reject ReCell

Tissue engineering specialist Clinical Cell Culture (ASX:CCE, C3) has clarified aspects of its application for approval to market its ReCell product in Australia, following a decision by the Therapeutic Goods Administration (TGA) in December to reject approval for the product.

ReCell is an autologous cell harvesting device used to treat wounds and other skin defects. The product received European CE Mark approval in March and is available for sale in 26 countries, including Germany, France, United Kingdom, Italy and Japan.

"[The TGA] have raised some concerns and we are now answering those concerns," said C3's CEO Troels Jordansen. "We have 20 working days to answer the concerns."

The TGA is seeking additional information and clarification in the areas of clinical data, product information labels, printed instructions for use and viral safety testing for ReCell.

"They have spotted a couple of things which in hindsight we can see could have been worded better or more clearly in our submission," said Jordansen. "We are comfortable that in February we will be able to submit answers to the TGA which answers their concerns. Then we can only pray and hope that the TGA will evaluate these answers at the meeting in March at which they are going to discuss their intention to reject ReCell."

Jordansen said none of the TGA's questions would require further testing or evaluation of ReCell. Instead, he said, "they are matters that we believe we can answer efficiently by reformatting and rewording parts" of the application.

The TGA's concerns in relation to clinical data are not due to lack of data or weak data, said Jordansen, but "purely because we told the TGA we were working on more information and they've showed a healthy interest in what we are working on."

In relation to product information labels and printed instructions for use, Jordansen said that: "Despite investigation, evaluation and assessment by many health authorities around the world, we can still improve on the instructions for use. We don't believe there are any mistakes in there, but we can understand how it can be read so that it's misleading."

Viral safety testing on ReCell is being conducted by a sub-supplier and while retesting will not be required, C3 will need to clarify information supplied to the TGA so "the TGA are not in doubt about what we actually mean," said Jordansen.

Jordansen was quick to praise the TGA. "They are highly qualified, they are specialised, they do this for a living," he said. However, "when you work with very complicated scientific and technical areas that have to be translated into a language that is universally understood in England, America, Singapore, Australian and New Zealand, once in a while you are not 100 per cent effective. But the TGA is helping us to get to that point."

While C3 is confident that ReCell will ultimately gain approval for sale in Australia, if the TGA needs further clarification after its meeting in March, C3 may need to submit further information for a June meeting.

"Let's not forget that we are not answering these questions in darkness," said Jordansen. "We are not just sitting and answering in isolation, we are doing it with support from the TGA."

C3's shares fell to a low of AUD$0.20 on December 21 when it announced that the TGA intended to reject ReCell for sale in Australia, down $0.09 (nearly a third) from the day before. Shares were trading at $0.024 at the time of writing, up $0.005 since trade opened this morning.