finally an announcement, page-5

I refer to some previous postings by those who attended the AGM and asked questions, notably tis-student,
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rock555: "did they mention anything about the 6 months notice to EMA before review as mentioned in previous posts?"

The management said 6 months notice to EMA before review is
not applicable to TIS.
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hazchem68: "A couple of things, did TIS explain why EMA only need to undertake 20% of the review and will this equate to taking approx 1/5th of the usual review process time?"
The only item left for EMA review for sale approval is manufacturing and quality data. Other items have already been approved (eg clinical trials, product safety, etc).
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Some info from AGM and chat with management after AGM:

1. TIS has sent a letter to EMA requesting a review start date. We are ready.

The average time for full drug review is 192 days. Because EMA review on TIS manufacturing and quality data is about 20% of the full review, the time should be less (approval should be in the first half of 2013).

2. Vitrogro in the warehouses is frozen and lasts many many years. The expiry date is 18 months after the approval date for sale.

3. Sale price for Vitrogro is 130 Euros per unit. Each pallet has 4000 units worth more than half a million Euros. I forgot to ask how many pallets are in the warehouses.
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As a result of an enquiry to TIS through their website I clarified the following:

A letter was sent to EMA by BIS as soon as they found out from MHRA that the matter should be referred to EMA. That letter asked for a review start date ASAP and TIS believes that the 6 month period is not a hard and fast rule.

Secondly, they have not ruled out seeking an accelerated review process based on the advantages of VG but they don't believe it will be accepted as they have been led to understand that such acceleration is reserved for significant life threatening situations.

Finally I have done some research on the EMA website and found the following in relation to reviews such as ours:
- Only 9 reviews since 2005 have been listed on their website and all were approved. (Either they don't list non-approvals or they don't get many referrals - let's hope its the latter)
- The average time from application to start date is 40 days (range 10 to 87 days)
- The average time from application to final approval is 307 days (range 209 to 468 days)
- In every instance CHMP asked questions of the applicant and there was a delay while they were answered
- The longest delays were caused by the manufacturer rather tham EMA
- The median approval was about 262 days

If we assume VG goes along the same lines as the median previous product the review should start later this month and approval should be given in about June or July next year.

DYOR

Rev
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On the basis of this information it is possible the system may work a little faster than the worst case scenario. Given the record and dissapointment of past time lines it is understandable the management will not suggest anything but the longest time frame.
If you read this forum then the announcment information is already known. Finally they offer bare bones information, and it all shows a total disconnect between management and investors that the management didn't think it needed to offer such basic facts at the AGM when they had the chance.
As suggested there is a mountain of other information we would all like to know, but the chances of getting that are zip. But do try the direct approach and report, unfortunately I have never had a reply to any question, but some have.