pAKKI
Read my post. I was referring to an announcement on the Confirmation of funding and initiation of Phase 2 details. No one said phase 2 will start in 1-2 weeks. Another of your arrogance in assuming that you are the smartest guy in the room.
At all cost you just had to latch on to part of the sentence and make a meal of it. I know your intention.
Anyway,
After the funding confirmation, there will be the design of the Phase II trial, the recruitment and the actual 5 weeks Phase 2a trial. As Phase IIa is with larger sample of healthy individuals, once the funding is confirmed, it will be essentially a larger Phase 1.
In the case of Phase 2a of ATL 1102, it was in 2004 when Antisense was still new. It took 6 month for the actual trial to start after Phase 1 result.
At the time there was no Pharma doing DD after Phase 1, no other 2nd gen antisense drug such as Mipomersen existed.
In 2012, we have a pharma doing DD immediately after Phase 1, we have mipomersen trials pathway experience all the way to seeking FDA approval. This will inevitably create very high confidence in Antisense drugs, funding options will improve and the experience gained from the previous ATL1102 phase 2 trials will benefit the design of Phase 2 trials for ATL 1103. Because of these reasons, I believe the funding details and the commencement dates may be announced in the next 1-2 weeks. The aim should be to have Phase 2a completed by Q4
The thinking of doing the Phase 2a trial without partnering a pharma is probably based on the ATL1102 experience with Teva. That way, ANP do not have to be affected by the internal agenda of the partnering pharma. Unless of course there is an offer too good to be refused.
The funding for Phase 2 probably will be the most important part of the trial. Once it is fully funded, it can go full steam ahead. Just have to look at Mipomersen 's timeline for guidance.
What we want is for a big Pharma to come in during this year for any of the 3 compounds, thus value ANP multiple times its current MC.
DYOR
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