Correct me if I am wrong but below is the key timeline of various approvals since 2020 :
18/03/2020 - FDA Breakthrough Device approved
01/04/2020 - CE marking approval04/05/2020 - ASEAN and APAC approval
01/06/2020 - Singapore Approval
02/07/2020 - TGA application SUBMITTED28/07/2020 - FDA HDE Submission28/08/2020 - Malaysian approval granted
22/10/2020 - First Commercial Sale
05/11/2020 - Swiss Approval
02/12/2020 - Termination of Daniel Kenny (ex- CEO)Feb/2021 - Announcement mentions that further supporting document submitted to TGA as requested.Now, if TGA was going to reject application simply based on how the Panco study was conducted or data was not sufficient then they could have done it in October 2020 and not asked for more document to support the application... IMO.
Nigel was in charge when new documents were submitted in January 2021 and he had opportunity to withdraw the application but he submitted application and even with shareholder conference they didn't mentioned anything... IMO.
Now a TGA meeting was due on 10th June and a week out of the meeting application was withdrawn with "ASSUMPTION" not based on any response from TGA that the application won't be supported... The announcement didn't provide any clear information on why company wakes up now to withdraw based on company's new "assumption" that application won't be supported by TGA based on data available when it could have withdrawn application back in January 2021 when data was submitted... IMO.
I do not believe that TGA provides hint or leak the news before the meeting so company can withdraw application. So removal of the previous CEO even though number of milestone were achieved in 2020 except the sale in EU and then sudden withdrawal of the application from TGA a week before meeting makes me suspicious of the intention (to withdraw TGA application) in absence of any evidence as political then scientific... IMO.
Regarding FDA, HDE filling they are saying the same thing for many months that they are waiting to get access to the hospital for the data and now it has been almost a year since the application submitted without any outcome. I am not a doctor but the word "DATA" seems more like digital information which I am surprised that they are unable to get through internet ... IMO.
Now after 6 years and number of approval as above the CEO was terminated and in the announcement no specific reason provided except the fact that no EU sale is expected until end of the year which is 8 month after CE approval. So if TGA had approved application then EU sale would be the only issue or drawback of previous CEO but I thought he already hired Nigel to address the sale in EU.. IMO... so why was he terminated is the mystery.
Nigel was EU representative at that time of removal of previous CEO so basically he had 7 months since last CEO departed and still no sale in EU under Nigel... In July it will be 1 year since CE marking approval granted in Europe so if we don't get sale in next 2 week then it is a long time ideal sitting product burning shareholder fund without any tangible outcome.
As per above timeline 2020 was superb year for the company as far as achieving milestones and submitting applications while we are now 6 month into 2021 and still not a single positive price sensitive announcement except Hong-Kong approval which I provided few days before the company announcement... which makes me think that current management prefer to remain silent... IMO... They have not submitted any new application to China/India/Japan/Korea... which they could have done it while they wait to get access to the hospitals.. IMO.
I also note that following three directors were in company when Daniel Kenny was CEO and submitted applications and decided path to get approval through various agencies so if Daniel was removed for any failure then these guys should also leave company as they were equally responsible particularly previous chairman who would have approved Daniel's strategy .. IMO.
| Mr Michael John Bassett | Non-Executive Director | Since Dec 2018 | |
|---|
| Dr Martin George Cross | Non-Executive Director | Since Feb 2017 | |
| Dr Roger Aston | Non-Executive Director | Since Sep 2014 |
Company should be out and about and certainly be more active in announcements and engaging shareholders. I also understand biotechnology is not a mining exploration company which can announce one bore hole result in a hope to pump the price ... but they should also show the shareholders what is happening behind the scene regularly and not wait for quarterly update to make announcements.. IMO.
(20min delay)
