Sir, my assumption and logic behind TGA application withdrawal is clear.
OSL submitted TGA application under previous CEO.
TGA asked question on the documents submitted. OSL didn't inform market when they received question but instead they told market when they responded to the questions. my understanding is that it took them few months to work on those questions. Nigel was in OSL when response provided to TGA.
Now, if someone ask you question then there are three possible pathways:
1. You know the answer with confidence and you respond.
2. You know that your answer is not going to work but you still go ahead, spend money and time and respond to TGA.
3. You know that your answer not going to work and you come honest to the shareholders and decide to withdraw.
If OSL went on no. 1 above then there is no reason to withdraw as they only responded because they knew they had enough data to support application to respond and that is why they spend time (few months) and money to respond. If TGA still reject it then it is better to let TGA reject it because that provides clear definitive answer in writing to OSL for future work as to what was missing. Money spend would have some outcome and future work can start from that point onward if company decides to go that way.
If OSL went on no. 2 above then they wasted company fund and time and mislead the investors in December when they said that they have submitted TGA application and awaiting response. As they should not have responded to TGA questions but instead should have gone to path 3 above.
If they went on no. 1 above then there is no way TGA will leak in advance with notice to OSL saying "take your application back as we will be rejecting it". If OSL has received official letter from TGA indicating that application would be rejected then in OSL announcement they would have clearly used the word "TGA provided indication" but instead they made an assumption that "we believe it won't go through" so why on earth he submitted application answers? Was company sleeping when response provided to TGA? There was investor conference where shareholder did ask about TGA and board mentioned that they are waiting for response.
Had TGA approved application then OSL decision to remove previous CEO would look dumb as previous CEO got OSL through EU & AU. Sell of products in AU won't be the problem considering how they are selling in NZ.. IMO.
So, issue is trust. How would you trust the management who keep telling you we are working on questions from authority and one day wake-up to find that they think it won't work.... ! Same could happens to FDA application who knows, as how can you trust them?
Regarding, EU sell. London has more then 100k cases their hospitals are open so is in EU. The device is not covered by NHS to my knowledge so they have to sell it to private patients only and to believe that in the entire Europe there are no pancreatic cancer patient in entire 24 month who would pay for the device is simply not possible. so again trust is the issue... IMO.
I do not question educational or professional competency of any of the board member as in my past post I said that they all have relevant industry experience and / or education, but honesty and trust is missing in my opinion.
company definitely looking to do cape raise and if they don't sell in Europe or come clean on why they can't sell in last 24 months then it will be hard to find investors who would put their fund in it... IMO.
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Last
$1.01 |
Change
-0.025(2.43%) |
Mkt cap ! $14.29M |
Open | High | Low | Value | Volume |
$1.04 | $1.05 | $1.00 | $41.05K | 40.86K |
Buyers (Bids)
No. | Vol. | Price($) |
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1 | 500 | $1.01 |
Sellers (Offers)
Price($) | Vol. | No. |
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$1.05 | 1249 | 1 |
View Market Depth
No. | Vol. | Price($) |
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1 | 17640 | 1.000 |
1 | 1000 | 0.990 |
1 | 2875 | 0.980 |
2 | 6000 | 0.970 |
1 | 1000 | 0.960 |
Price($) | Vol. | No. |
---|---|---|
1.045 | 1249 | 1 |
1.050 | 25048 | 2 |
1.075 | 1879 | 1 |
1.090 | 375 | 1 |
1.180 | 2500 | 1 |
Last trade - 15.47pm 20/06/2025 (20 minute delay) ? |
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